BIPOL.PEN 25G 2PIN TAPER 12/BX E7924

GUDID 04058935000530

Single Use Medical Device for Ophthalmic Surgery

Bausch & Lomb GmbH

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Primary Device ID04058935000530
NIH Device Record Keyd9300a4a-1654-4e7e-b168-6a36ade1e21e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIPOL.PEN 25G 2PIN TAPER 12/BX
Version Model NumberE7924
Catalog NumberE7924
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
GS104058935000530 [Primary]
GS124058935000534 [Unit of Use]

FDA Product Code

GXIProbe, Radiofrequency Lesion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-29
Device Publish Date2016-07-15

Devices Manufactured by Bausch & Lomb GmbH

24058935003450 - 23G ENDGRIPPING FORCEPS 12/BX2024-07-17 Single Use Medical Device for Ophthalmic Surgery
24058935003474 - 25G ENDGRIPPING FORCEPS 12/BX2024-07-17 Single Use Medical Device for Ophthalmic Surgery
24058935004945 - CAPSULORHEXIS FORCEPS 12/BOX2024-07-17 Single Use Medical Device for Ophthalmic Surgery
24058935004969 - BONN FORCEPS 12/BOX2024-07-17 Single Use Medical Device for Ophthalmic Surgery
24058935004983 - TYING FORCEPS STRAIGHT 12/BOX2024-07-17 Single Use Medical Device for Ophthalmic Surgery
24058935005003 - MCPHERSON TYING FORCEPS 12/BOX2024-07-17 Single Use Medical Device for Ophthalmic Surgery
24058935005027 - PIERSE TYING FORCEPS 12/BOX2024-07-17 Single Use Medical Device for Ophthalmic Surgery
24058935005041 - MICS CAPSULORHEXIS FORCEPS 12/BOX2024-07-17 Single Use Medical Device for Ophthalmic Surgery

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