ФСЗ 2012/11761

Регистрационное удостоверение на медицинское изделие ФСЗ 2012/11761

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Внимание, документ содержит изменения: История вносимых изменений

Наименование

Ножи офтальмологическиеварианты исполнения:
1. 15 deg. Ophthalmic knife.
2. 22.5 deg. Ophthalmic knife.
3. 30 deg. Ophthalmic knife.
4. 45 deg. Ophthalmic knife.
5. 19 ga. V-lance - Full Handle.
6. 20 ga V-lance - Full Handle.
7. 23 ga. MVR Blade VitRet Handle.
8. 25 ga. MVR Blade VitRet Handle.
9. Angled Disc Knife.
10. Straight Satin Crescent Knife.
11. Bevel Up Satin Crescent Knife.
12. 2.5 mm Angled Satin Slit Knife.
13. 2.6 mm ClearCut Angled Satin Slit Knife.
14. 2.75 mm ClearCut Angled Satin Slit Knife.
15. 2.75 mm Angled Satin Slit Knife.
16. 3.0 mm Angled Satin Slit Knife.
17. 3.0 mm ClearCut Angled Satin Slit Knife.
18. 3.2 mm Angled ClearCut Slit Knife.
19. 3.2 mm Angled Satin Slit Knife.
20. 3.4 mm Angled ClearCut Knife.
21. 3.2 mm Angled Satin ShortCut Slit Knife.
22. 3.5 mm Angled Satin ShortCut Slit Knife.
23. 4.1 mm Angled Satin ShortCut Slit Knife.
24. 5.2 mm Angled Satin ShortCut Slit Knife.
25. I-Knife 15 deg. Knife.
26. I-Knife Angled Disc Knife.
27. I-Knife II 3 mm 15 deg. Ophthalmic knife.
28. I-Knife II 5 mm 15 deg. Ophthalmic knife.
29. I-Knife II 2.75 mm Angled Satin Slit Knife.
30. I-Knife II 3.0 mm Angled Satin Slit Knife.
31. I-Knife II 3.2 mm Angled Satin Slit Knife.
32. 15 deg. Ophthalmic knife Threaded Tip.
33. 22.5 deg. Ophthalmic knife Threaded Tip.
34. 30 deg. Ophthalmic knife Threaded Tip.
35. MacKool Sideport knife.
36. 57 Flat Stock.
37. 64 Flat Stock.
38. 66 Flat Stock.
39. 67 Flat Stock.
40. 69 Flat Stock.
41. ClearCut TM Dual Bevel 1.0 mm Angled SidePort Knife.
42. ClearCut TM Dual Bevel 1.2 mm Angled SidePort Knife.
43. ClearCut TM Dual Bevel 1.5 mm Angled SidePort Knife.
44. ClearCut TM Dual Bevel 3.2 mm Angled Implant Knife.
45. ClearCut TM Dual Bevel 3.5 mm Angled Implant Knife.
46. ClearCut TM Dual Bevel 3.7 mm Angled Implant Knife.
47. ClearCut TM Dual Bevel 4.1 mm Angled Implant Knife.
48. ClearCut TM Dual Bevel 5.2 mm Angled Implant Knife.
49. ClearCut TM Dual Bevel 5.5 mm Angled Implant Knife.
50. ClearCut TM Dual Bevel 6.0 mm Angled Implant Knife.
51. ClearCut TM Dual Bevel 2.6 mm Angled Slit Knife.
52. ClearCut TM Dual Bevel 2.75 mm Angled Slit Knife.
53. ClearCut TM Dual Bevel 3.0 mm Angled Slit Knife.
54. ClearCut TM Dual Bevel 3.2 mm Angled Slit Knife.
55. ClearCut TM Single Bevel 1.8 mm Slit Knife for Intrepid TM.
56. ClearCut TM Single Bevel 2.0 mm Slit Knife for Intrepid TM.
57. ClearCut TM Single Bevel 2.2 mm Slit Knife for Intrepid TM.
58. ClearCut TM Single Bevel 2.4 mm Slit Knife for Intrepid TM.
59. ClearCut TM HP Dual Bevel 2.6 mm Angled Slit Knife.
60. ClearCut TM HP Dual Bevel 2.8 mm Angled Slit Knife.
61. ClearCut TM HP Dual Bevel 3.0 mm Angled Slit Knife.
62. ClearCut TM HP Dual Bevel 3.2 mm Angled Slit Knife.
63. ClearCut TM HP Dual Bevel Angled Crescent Knife.
64. ClearCut TM HP2 Dual Bevel 1.8 mm Angled Slit Knife for Intrepid TM MicroCoaxial System.
65. ClearCut TM HP2 Dual Bevel 2.0 mm Angled Slit Knife for Intrepid TM MicroCoaxial System.
66. ClearCut TM HP2 Dual Bevel 2.2 mm Angled Slit Knife for Intrepid TM MicroCoaxial System.
67. ClearCut TM HP2 Dual Bevel 2.4 mm Angled Slit Knife for Intrepid TM MicroCoaxial System.
68. ClearCut TM HP2 Dual Bevel 2.6 mm Angled Slit Knife.
69. ClearCut TM HP2 Dual Bevel 2.8 mm Angled Slit Knife.
70. ClearCut TM HP2 Dual Bevel 3.0 mm Angled Slit Knife.
71. ClearCut TM HP2 Dual Bevel 3.2 mm Angled Slit Knife.
72. ClearCut TM S A-OK Slit 2.5 mm.
73. ClearCut TM S A-OK Slit 2.75 mm.
74. ClearCut TM S Slit 2.6 mm.
75. ClearCut TM S Slit 2.75 mm.
76. ClearCut TM S Slit DB 2.6 mm.
77. ClearCut TM S Slit DB 2.75 mm.
78. ClearCut TM S HP Slit 2.6 mm.
79. ClearCut TM S HP2 Slit 2.6 mm.
80. ClearCut TM S Intrepid DB 2.2 mm.
81. ClearCut TM S Intrepid DB 2.4 mm.
82. ClearCut TM S Intrepid SB 2.2 mm.
83. ClearCut TM S Intrepid SB 2.4 mm.
84. ClearCut TM S 150 SAB Sideport.
85. ClearCut TM S 22.50 SAB Sideport.
86. ClearCut TM S 300 SAB Sideport.
87. ClearCut TM S 1.0 mm Sideport.
88. ClearCut TM S 1.2 mm Sideport.
89. ClearCut TM S 2.3 mm Crescent.
90. ClearCut TM S 2.3 mm Crescent DB.
91. ClearCut TM S 2.3 mm HP Crescent.

Номер РУ

ФСЗ 2012/11761

Дата РУ

20.11.2019

Срок действия РУ

Бессрочно

Номер реестровой записи

39542

Заявитель

ООО "Алкон Фармацевтика"

Фактический адрес заявителя

125315, Россия, г. Москва, Ленинградский проспект, д. 72, корп. 3

Юридический адрес заявителя

125315, Россия, г. Москва, Ленинградский проспект, д. 72, корп. 3

Изготовитель

"Алкон Лабораториз, Инк."

Фактический адрес изготовителя

, США, Дальнее зарубежье, Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, Texas 76134-2099, USA

Юридический адрес изготовителя

, США, Дальнее зарубежье, Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, Texas 76134-2099, USA

Код ОКП/ОКПД2

32.50.13.120

Класс риска

2а

Вид

171840

Таблица пуста

Адрес

Alcon Research LLC, 714 Columbia avenue, Sinking Spring, PA 19608, USA

Модели медицинского изделия

Код вида

Наименование модели

Таблица пуста

171840

Ножи офтальмологические

История вносимых изменений

Наименование

Номер РУ

Дата РУ

Изготовитель

Код ОКП/ОКПД2

Вид

Скачать скан РУ

Ножи офтальмологическиеварианты исполнения: 1. 15 deg. Ophthalmic knife 2. 22.5 deg. Ophthalmic knife 3. 30 deg. Ophthalmic knife 4. 45 deg. Ophthalmic knife 5. 19 ga. V-lance - Full Handle 6. 20 ga V-lance - Full Handle 7. 23 ga. MVR Blade VitRet Handle 8. 25 ga. MVR Blade VitRet Handle 9. Angled Disc Knife 10. Straight Satin Crescent Knife 11. Bevel Up Satin Crescent Knife 12. 2.5 mm Angled Satin Slit Knife 13. 2.6 mm ClearCut Angled Satin Slit Knife 14. 2.75 mm ClearCut Angled Satin Slit Knife 15. 2.75 mm Angled Satin Slit Knife 16. 3.0 mm Angled Satin Slit Knife 17. 3.0 mm ClearCut Angled Satin Slit Knife 18. 3.2 mm Angled ClearCut Slit Knife 19. 3.2 mm Angled Satin Slit Knife 20. 3.4 mm Angled ClearCut Knife 21. 3.2 mm Angled Satin ShortCut Slit Knife 22. 3.5 mm Angled Satin ShortCut Slit Knife 23. 4.1 mm Angled Satin ShortCut Slit Knife 24. 5.2 mm Angled Satin ShortCut Slit Knife 25. I-Knife 15 deg. Knife 26. I-Knife Angled Disc Knife 27. I-Knife II 3 mm 15 deg. Ophthalmic knife 28. I-Knife II 5 mm 15 deg. Ophthalmic knife 29. I-Knife II 2.75 mm Angled Satin Slit Knife 30. I-Knife II 3.0 mm Angled Satin Slit Knife 31. I-Knife II 3.2 mm Angled Satin Slit Knife 32. 15 deg. Ophthalmic knife Threaded Tip 33. 22.5 deg. Ophthalmic knife Threaded Tip 34. 30 deg. Ophthalmic knife Threaded Tip 35. MacKool Sideport knife 36. 57 Flat Stock 37. 64 Flat Stock 38. 66 Flat Stock 39. 67 Flat Stock 40. 69 Flat Stock 41. ClearCut TM Dual Bevel 1.0 mm Angled SidePort Knife 42. ClearCut TM Dual Bevel 1.2 mm Angled SidePort Knife 43. ClearCut TM Dual Bevel 1.5 mm Angled SidePort Knife 44. ClearCut TM Dual Bevel 3.2 mm Angled Implant Knife 45. ClearCut TM Dual Bevel 3.5 mm Angled Implant Knife 46. ClearCut TM Dual Bevel 3.7 mm Angled Implant Knife 47. ClearCut TM Dual Bevel 4.1 mm Angled Implant Knife 48. ClearCut TM Dual Bevel 5.2 mm Angled Implant Knife 49. ClearCut TM Dual Bevel 5.5 mm Angled Implant Knife 50. ClearCut TM Dual Bevel 6.0 mm Angled Implant Knife 51. ClearCut TM Dual Bevel 2.6 mm Angled Slit Knife 52. ClearCut TM Dual Bevel 2.75 mm Angled Slit Knife 53. ClearCut TM Dual Bevel 3.0 mm Angled Slit Knife 54. ClearCut TM Dual Bevel 3.2 mm Angled Slit Knife 55. ClearCut TM Single Bevel 1.8 mm Slit Knife for Intrepid TM 56. ClearCut TM Single Bevel 2.0 mm Slit Knife for Intrepid TM 57. ClearCut TM Single Bevel 2.2 mm Slit Knife for Intrepid TM 58. ClearCut TM Single Bevel 2.4 mm Slit Knife for Intrepid TM 59. ClearCut TM HP Dual Bevel 2.6 mm Angled Slit Knife 60. ClearCut TM HP Dual Bevel 2.8 mm Angled Slit Knife 61. ClearCut TM HP Dual Bevel 3.0 mm Angled Slit Knife 62. ClearCut TM HP Dual Bevel 3.2 mm Angled Slit Knife 63. ClearCut TM HP Dual Bevel Angled Crescent Knife 64. ClearCut TM HP2 Dual Bevel 1.8 mm Angled Slit Knife for Intrepid TM MicroCoaxial System 65. ClearCut TM HP2 Dual Bevel 2.0 mm Angled Slit Knife for Intrepid TM MicroCoaxial System 66. ClearCut TM HP2 Dual Bevel 2.2 mm Angled Slit Knife for Intrepid TM MicroCoaxial System 67. ClearCut TM HP2 Dual Bevel 2.4 mm Angled Slit Knife for Intrepid TM MicroCoaxial System 68. ClearCut TM HP2 Dual Bevel 2.6 mm Angled Slit Knife 69. ClearCut TM HP2 Dual Bevel 2.8 mm Angled Slit Knife 70. ClearCut TM HP2 Dual Bevel 3.0 mm Angled Slit Knife 71. ClearCut TM HP2 Dual Bevel 3.2 mm Angled Slit Knife 72. ClearCut TM S A-OK Slit 2.5 mm 73. ClearCut TM S A-OK Slit 2.75 mm 74. ClearCut TM S Slit 2.6 mm 75. ClearCut TM S Slit 2.75 mm 76. ClearCut TM S Slit DB 2.6 mm 77. ClearCut TM S Slit DB 2.75 mm 78. ClearCut TM S HP Slit 2.6 mm 79. ClearCut TM S HP2 Slit 2.6 mm 80. ClearCut TM S Intrepid DB 2.2 mm 81. ClearCut TM S Intrepid DB 2.4 mm 82. ClearCut TM S Intrepid SB 2.2 mm 83. ClearCut TM S Intrepid SB 2.4 mm 84. ClearCut TM S 150 SAB Sideport 85. ClearCut TM S 22.50 SAB Sideport 86. ClearCut TM S 300 SAB Sideport 87. ClearCut TM S 1.0 mm Sideport 88. ClearCut TM S 1.2 mm Sideport 89. ClearCut TM S 2.3 mm Crescent 90. ClearCut TM S 2.3 mm Crescent DB 91. ClearCut TM S 2.3 mm HP Crescent

ФСЗ 2012/11761

08.09.2016

ООО "Алкон Фармацевтика"

94 3300

171840

Развернуть

Ножи офтальмологические (см. Приложение на 4 листах)I. Ножи офтальмологические, варианты исполнения: 1. 15 deg. Ophthalmic knife 2. 22.5 deg. Ophthalmic knife 3. 30 deg. Ophthalmic knife 4. 45 deg. Ophthalmic knife 5. 19 ga. V-lance - Full Handle 6. 20 ga V-lance - Full Handle 7. 23 ga. MVR Blade VitRet Handle 8. 25 ga. MVR Blade VitRet Handle 9. Angled Disc Knife 10. Straight Satin Crescent Knife 11. Bevel Up Satin Crescent Knife 12. Bevel Down Satin Crescent Knife 13. 2.6 mm Angled Slit Knife 14. 2.5 mm Angled Satin Slit Knife 15. 2.6 mm ClearCut Angled Satin Slit Knife 16. 2.75 mm Straight Satin Slit Knife 17. 2.75 mm ClearCut Angled Satin Slit Knife 18. 2.75 mm Angled Satin Slit Knife 19. 3.0 mm Straight Satin Slit Knife 20. 3.0 mm Angled Satin Slit Knife 21. 3.0 mm ClearCut Angled Satin Slit Knife 22. 3.2 mm Straight Satin Slit Knife 23. 3.2 mm Angled ClearCut Slit Knife 24. 3.2 mm Angled Satin Slit Knife 25. 3.4 mm Angled ClearCut Knife 26. 3.0 mm Angled Satin DupliCut Slit Knife 27. 3.2 mm Angled Satin DupliCut Slit Knife 28. 3.2 mm Angled Satin ShortCut Slit Knife 29. 3.5 mm Angled Satin ShortCut Slit Knife 30. 4.1 mm Angled Satin ShortCut Slit Knife 31. 5.2 mm Straight Satin ShortCut Slit Knife 32. 5.2 mm Angled Satin ShortCut Slit Knife 33. I-Knife 15 deg. Knife 34. I-Knife 22.5 deg. Knife 35. I-Knife 30 deg. Knife 36. I-Knife 45 deg. Knife 37. I-Knife Angled Disc Knife 38. I-Knife II 3 mm 15 deg. Ophthalmic knife 39. I-Knife II 5 mm 15 deg. Ophthalmic knife 40. I-Knife II Straight Satin Crescent knife 41. I-Knife II Bevel Up Satin Crescent knife 42. I-Knife II Bevel Down Satin Crescent knife 43. I-Knife II 2.75 mm Angled Satin Slit Knife 44. I-Knife II 3.0 mm Angled Satin Slit Knife 45. I-Knife II 3.2 mm Angled Satin Slit Knife 46. 15 deg. Ophthalmic knife Threaded Tip 47. 22.5 deg. Ophthalmic knife Threaded Tip 48. 30 deg. Ophthalmic knife Threaded Tip 49. 45 deg. Ophthalmic knife Threaded Tip 50. MacKool Sideport knife 51. 1.0 mm Access Paracentecis Blade 52. 57 Flat Stock 53. 64 Flat Stock 54. 66 Flat Stock 55. 67 Flat Stock 56. 69 Flat Stock 57. 67 (1 mm) Flat Stock 58. ClearCut TM Dual Bevel 1.0 mm Angled SidePort Knife 59. ClearCut TM Dual Bevel 1.2 mm Angled SidePort Knife 60. ClearCut TM Dual Bevel 1.5 mm Angled SidePort Knife 61. ClearCut TM Dual Bevel 3.2 mm Straight Slit Knife 62. ClearCut TM Dual Bevel 3.2 mm Angled Implant Knife 63. ClearCut TM Dual Bevel 3.5 mm Angled Implant Knife 64. ClearCut TM Dual Bevel 3.7 mm Angled Implant Knife 65. ClearCut TM Dual Bevel 4.1 mm Angled Implant Knife 66. ClearCut TM Dual Bevel 5.2 mm Angled Implant Knife 67. ClearCut TM Dual Bevel 5.5 mm Angled Implant Knife 68. ClearCut TM Dual Bevel 6.0 mm Angled Implant Knife 69. ClearCut TM Dual Bevel 2.6 mm Angled Slit Knife 70. ClearCut TM Dual Bevel 2.75 mm Angled Slit Knife 71. ClearCut TM Dual Bevel 3.0 mm Angled Slit Knife 72. ClearCut TM Dual Bevel 3.2 mm Angled Slit Knife 73. ClearCut TM Dual Bevel 3.4 mm Angled Slit Knife 74. ClearCut TM Dual Bevel Angled Crescent Knife 75. ClearCut TM Single Bevel 1.8 mm Slit Knife for Intrepid TM 76. ClearCut TM Single Bevel 2.0 mm Slit Knife for Intrepid TM 77. ClearCut TM Single Bevel 2.2 mm Slit Knife for Intrepid TM 78. ClearCut TM Single Bevel 2.4 mm Slit Knife for Intrepid TM 79. ClearCut TM HP Dual Bevel 2.6 mm Angled Slit Knife 80. ClearCut TM HP Dual Bevel 2.8 mm Angled Slit Knife 81. ClearCut TM HP Dual Bevel 3.0 mm Angled Slit Knife 82. ClearCut TM HP Dual Bevel 3.2 mm Angled Slit Knife 83. ClearCut TM HP Dual Bevel Angled Crescent Knife 84. ClearCut TM HP2 Dual Bevel 1.8 mm Angled Slit Knife for Intrepid TM MicroCoaxial System 85. ClearCut TM HP2 Dual Bevel 2.0 mm Angled Slit Knife for Intrepid TM MicroCoaxial System 86. ClearCut TM HP2 Dual Bevel 2.2 mm Angled Slit Knife for Intrepid TM MicroCoaxial System 87. ClearCut TM HP2 Dual Bevel 2.4 mm Angled Slit Knife for Intrepid TM MicroCoaxial System 88. ClearCut TM HP2 Dual Bevel 2.6 mm Angled Slit Knife 89. ClearCut TM HP2 Dual Bevel 2.8 mm Angled Slit Knife 90. ClearCut TM HP2 Dual Bevel 3.0 mm Angled Slit Knife 91. ClearCut TM HP2 Dual Bevel 3.2 mm Angled Slit Knife 92. ClearCut TM S A-OK Slit 2.5 mm 93. ClearCut TM S A-OK Slit 2.75 mm 94. ClearCut TM S Slit 2.6 mm 95. ClearCut TM S Slit 2.75 mm 96. ClearCut TM S Slit DB 2.6 mm 97. ClearCut TM S Slit DB 2.75 mm 98. ClearCut TM S HP Slit 2.6 mm 99. ClearCut TM S HP2 Slit 2.6 mm 100. ClearCut TM S Intrepid DB 2.2 mm 101. ClearCut TM S Intrepid DB 2.4 mm 102. ClearCut TM S Intrepid SB 2.2 mm 103. ClearCut TM S Intrepid SB 2.4 mm 104. ClearCut TM S 150 SAB Sideport 105. ClearCut TM S 22.50 SAB Sideport 106. ClearCut TM S 300 SAB Sideport 107. ClearCut TM S 1.0 mm Sideport 108. ClearCut TM S 1.2 mm Sideport 109. ClearCut TM S 2.3 mm Crescent 110. ClearCut TM S 2.3 mm Crescent DB 111. ClearCut TM S 2.3 mm HP Crescent II. Организация-изготовитель: - Alcon Research, Ltd., 714 Columbia Avenue, Sinking Spring, PA 19608-1404, USA.

ФСЗ 2012/11761

20.03.2012

94 3300

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Описание

01И-955/24 от 23.08.2024

Об отзыве медицинского изделия

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