In'Tech Medical 30mm Surgical Illuminator S06 ITM 232

GUDID 00812432021597

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 ID00812432021597
NIH Device Record Key55474ce4-3775-4d80-8a36-668bd11faf19
Commercial Distribution StatusIn Commercial Distribution
Brand NameIn'Tech Medical 30mm Surgical Illuminator
Version Model Number009568
Catalog NumberS06 ITM 232
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812432021597 [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