Precision Spine TLIF Bifurcated Surgical Illuminator 012628

GUDID 00812432022662

LUMITEX, INC.

Open surgical site internal light
Primary Device ID00812432022662
NIH Device Record Keyd1a4e533-ec2b-4a8a-be9c-5e73ec2e484d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Spine TLIF Bifurcated Surgical Illuminator
Version Model Number73-LC-5200
Catalog Number012628
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
GS100812432022662 [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

On-Brand Devices [Precision Spine TLIF Bifurcated Surgical Illuminator]

0081243202266273-LC-5200
0081243202304173-LC-5300

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.