MICS I/A SIL.TIP STRT STEL 12B 85914ST

GUDID 04058935000486

Single Use Medical Device for Ophthalmic Surgery

Bausch & Lomb GmbH

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID04058935000486
NIH Device Record Key3dbc8d04-e344-446d-b324-541d8d7d150d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICS I/A SIL.TIP STRT STEL 12B
Version Model Number85914ST
Catalog Number85914ST
Company DUNS342397433
Company NameBausch & Lomb GmbH
Device Count12
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104058935000486 [Primary]
GS124058935000480 [Unit of Use]

FDA Product Code

HQCUnit, Phacofragmentation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-10-07
Device Publish Date2016-07-15

Devices Manufactured by Bausch & Lomb GmbH

04058935000646 - PPT MICS 6/BX2019-11-08 Single Use Medical Device for Ophthalmic Surgery
04058935000653 - PPT CRYSTALENS 12/BX2019-11-08 Single Use Medical Device for Ophthalmic Surgery
04058935000011 - SIL I/A HANDP CURVED STELL 12/B 2019-10-07 Single Use Medical Device for Ophthalmic Surgery
04058935000028 - ASP HANDPIECE STERILE 12/BOX2019-10-07 Single Use Medical Device for Ophthalmic Surgery
04058935000035 - IRR HANDPIECE STERILE 12/BOX2019-10-07 Single Use Medical Device for Ophthalmic Surgery
04058935000042 - I/A HANDP.STRAIGHT,17G 12/BOX2019-10-07 Single Use Medical Device for Ophthalmic Surgery
04058935000059 - I/A HANDP.CURVED,17G 12/BOX2019-10-07 Single Use Medical Device for Ophthalmic Surgery
04058935000066 - I/A HANDPIECE CURVED 17G 12/B2019-10-07 Single Use Medical Device for Ophthalmic Surgery

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