K2M Light Adapter- ACMI AC01-90056

GUDID 00812432021337

LUMITEX, INC.

Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable Fibreoptic light cable
Primary Device ID00812432021337
NIH Device Record Keycc4ad9cf-2c9d-443b-adc8-67b7d6ac3a31
Commercial Distribution StatusIn Commercial Distribution
Brand NameK2M Light Adapter- ACMI
Version Model Number011902
Catalog NumberAC01-90056
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812432021337 [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 Date2022-02-22
Device Publish Date2022-02-14

Devices Manufactured by LUMITEX, INC.

00812432023010 - Thompson Surgical Instruments Lite Path Integrated Double 13mm2023-11-09
00812432022396 - Spineart Wolf Cable Adaptor2023-08-21
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

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