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Crédits
Devices
Device Recall BIOM PACK
Modèle / numéro de série
Cornea Coat Lot Codes: M408080708, M409570708, M414420808, M415940808, M415950808, M416620908, M419300908, M421610908, M421680908, M422951008, M427661108, M430041108, M435381208, M442120109, M44499, M44744, M44897.
Classification du dispositif
Ophthalmic Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.
Description du dispositif
BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope Drape (REF40100), 1 EA. Cornea Coat (REF 60010), 1 EA. SuperView BIOM Lens Set (REF 40411). || Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA. || Item # 40201: || Item Lot # Cornea Coat Lot # Expiration Date || M423801008 M419300908 2010-07 || M427731108 M419300908 2010-07 || M428631008 M419300908 2010-07 || M434211208 M422951008 2010-08 || M439670109 M422951008 2010-08 || M443700109 M435381208 2010-09 || M44887 M442120109 2010-10 || Item # 40202: || Item Lot # Cornea Coat Lot # Expiration Date || M427641008 M419300908 2010-07 || M45414 M435381208 2010-09 || Item # 40203: || M416600908 M415950808 2010-06 || M422941008 M416620908 2010-07 || M427651108 M422951008 2010-08 || M442710109 M435381208 2010-09 || M44870 M442120109 2010-10 || Item # 40204: || Item Lot # Cornea Coat Lot # Expiration Date || M421580908 M416620908 2010-07 || M435201208 M422951008 2010-08 || M45645 M435381208 2010-09 || Item # 40205: || Item Lot # Cornea Coat Lot # Expiration Date || M410510708 M409570708 2010-05 || M412790708 M409570708 2010-05 || M419280908 M415950808 2010-06 || M420850908 M415950808 2010-06 || M421100908 M416620908 2010-07 || M421120908 M416620908 2010-07 || M424361008 M419300908 2010-07 || M425821008 M421680908 2010-07 || M426731008 M421680908 2010-07 || M428601008 M419300908 2010-07 || M429531108 M421680908 2010-07 || M430851108 M421680908 2010-07 || M431051108 M422951008 2010-08 || M433111108 M422951008 2010-08 || M435531208 M430041108 2010-09 || M440700109 M430041108 2010-09 || M441790109 M435381208 2010-09 || M442560109 M430041108 2010-09 || M443450109 M422951008 2010-08 || M443930109 M442120109 2010-10 || M44605 M442120109 2010-10 || M44896 M44499 2010-11 || M45099 M44499 2010-11 || M45243 M435381208 2010-09 || M45248 M44897 2010-12 || M45866 M44897 2010-12 || M45870 M435381208 2010-09 || Item # 10206: || Item Lot # Cornea Coat Lot # Expiration Date || M418460908 M416620908 2010-07 || M434741208 M422951008 2010-08 || M45646 M435381208 2010-09
Manufacturer
Insight Instruments, Inc.
1 Event
Rappel de Device Recall BIOM PACK
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Fabricant
Insight Instruments, Inc.
Adresse du fabricant
Insight Instruments, Inc., 2580 Se Willoughby Blvd, Stuart FL 34994-4701
Société-mère du fabricant (2017)
Insight Instruments, Inc.
Source
USFDA
Language
English
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