Lumitex Medical Devices Adapter - ACMI

GUDID 00812432020385

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 ID00812432020385
NIH Device Record Key16b16ea6-5a81-4460-b2ea-f277baae8b8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumitex Medical Devices Adapter - ACMI
Version Model Number012140
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812432020385 [Primary]

FDA Product Code

FDGRetractor, Fiberoptic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-08
Device Publish Date2020-09-30

Devices Manufactured by LUMITEX, INC.

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00812432022921 - Spineart Olympus Cable Adaptor2023-08-21
00810025485344 - MiRus Bifurcated Illuminator2023-08-21
00812432021559 - Spineart Storz Cable Adaptor2023-08-21
00812432021689 - Lumitex 4mm Universal Fiber Optic Cable2023-08-21
00812432021696 - Lumitex 3.5mm Fiber Optic Cable2023-08-21
00812432022655 - Orthofix Surgical Illuminator2023-08-21

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