Spineart Surgical Illuminator MIS-IN 44 70-S

GUDID 00812432021436

LUMITEX, INC.

Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light Surgical instrument fibreoptic light
Primary Device ID00812432021436
NIH Device Record Key9852292d-3d2f-4d9c-91b5-f688f12d30ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpineart Surgical Illuminator
Version Model Number010996
Catalog NumberMIS-IN 44 70-S
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
GS100812432021436 [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 Date2020-10-08
Device Publish Date2020-09-30

On-Brand Devices [Spineart Surgical Illuminator]

00812432021436010996
00812432021429008612

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.