Spinal Elements PL Retractor Light 89100-000

GUDID 00812432022815

LUMITEX, INC.

Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light Open surgical site internal light
Primary Device ID00812432022815
NIH Device Record Key4e9d1b65-64b3-4880-abf4-3da97641231e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpinal Elements PL Retractor Light
Version Model Number012656
Catalog Number89100-000
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812432022815 [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 Date2022-05-03
Device Publish Date2022-04-25

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