Lumitex 3.5mm Fiber Optic Cable 012682

GUDID 00812432021696

LUMITEX, INC.

Open surgical site internal light
Primary Device ID00812432021696
NIH Device Record Keyde9efe27-9ce4-4cb3-a5cf-926baed87aad
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumitex 3.5mm Fiber Optic Cable
Version Model Number012004
Catalog Number012682
Company DUNS108631797
Company NameLUMITEX, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812432021696 [Primary]

FDA Product Code

FDGRetractor, Fiberoptic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-21
Device Publish Date2023-08-11

Devices Manufactured by LUMITEX, INC.

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00812432023171 - Medtronic 4mm ACMI Cable Adapter2026-01-15
00812432023188 - Medtronic 4mm WOLF Cable Adapter2026-01-15
00812432023195 - Medtronic 4mm OLYMPUS Cable Adapter2026-01-15
00812432023201 - Medtronic 4mm STORZ Cable Adapter2026-01-15
00812432023072 - L&K Biomed BluEX Surgical Illuminator2025-12-19

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