Bones and Nerves Disposable Single Leg Surgical Illuminator 012620

GUDID 00812432022747

LUMITEX, INC.

Open surgical site internal light
Primary Device ID00812432022747
NIH Device Record Key3e05e323-9332-4f88-ae7b-eeca92adefa3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBones and Nerves Disposable Single Leg Surgical Illuminator
Version Model NumberBNS-LT 10 01-S
Catalog Number012620
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 Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100812432022747 [Primary]

FDA Product Code

FDGRetractor, Fiberoptic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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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00812432023201 - Medtronic 4mm STORZ Cable Adapter2026-01-15
00812432023072 - L&K Biomed BluEX Surgical Illuminator2025-12-19

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