Lumitex 4mm Universal Fiber Optic Cable 012681

GUDID 00812432021689

LUMITEX, INC.

Open surgical site internal light
Primary Device ID00812432021689
NIH Device Record Key75d847a2-50e5-4c3f-95c9-c3439e53c6e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumitex 4mm Universal Fiber Optic Cable
Version Model Number012139
Catalog Number012681
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
GS100812432021689 [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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00812432023072 - L&K Biomed BluEX Surgical Illuminator2025-12-19

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