FDA.reportPublic FDA data

LITEX

Primary DI
05060792971785
Brand
LITEX
Company
Litex Manufacturing, Inc.
Model
50001203
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FTALight, Surgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060792971785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060792971785050607929717855060792971785

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment handle cover adaptorA connecting device intended to be used to connect the handle of a piece of medical equipment (e.g., operating light) with a handle cover, when these are incompatible and are of a different manufacture/industry standard. It is made of polymer and/or metallic materials and takes a form suitable for the devices to which it connects. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021129574
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00560792971716LITEX3660-9452025-08-01
05060792970009LITEX3600-12025-08-01
05060792970016Litex3600-102025-08-01
05060792970023LITEX3600-1042025-08-01
05060792970030LITEX3600-1072025-08-01
05060792970047Litex3600-10B2025-08-01
05060792970054LITEX3600-10H2025-08-01
05060792970061LITEX3600-122025-08-01
05060792970078LITEX3600-12S2025-08-01
05060792970085LITEX3600-132025-08-01
05060792970092LITEX3600-142025-08-01
05060792970115LITEX3600-172025-08-01
05060792970122LITEX3600-17B2025-08-01
05060792970139LITEX3600-17S2025-08-01
05060792970146LITEX3600-22025-08-01
05060792970153LITEX3600-222025-08-01
05060792970160LITEX3600-22H2025-08-01
05060792970177LITEX3600-232025-08-01
05060792970184LITEX3600-23B2025-08-01
05060792970191LITEX3600-242025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426144563Medline-MicrotekMicrotek Medical LLCFTA2026-02-18
10748426142931Skytron®Microtek Medical LLCFTA2026-02-05
10748426145024NAMicrotek Medical LLCFTA2026-02-05
00748426262700Medline-MicrotekMicrotek Medical LLCFTA2026-01-05
00724995245054HexaVueBLACK DIAMOND VIDEO, INC.FTA2025-10-17
00810008184943OlympusGyrus ACMI, LLCFTA2025-09-19
00810008185018OlympusGyrus ACMI, LLCFTA2025-09-19
00810008185032OlympusGyrus ACMI, LLCFTA2025-09-19
00810008185063OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047150OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047242OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047259OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047266OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047273OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047280OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047297OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047303OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047310OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047327OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047365Gyrus ACMIGyrus ACMI, LLCFTA2025-09-19
05060792970658LITEXLitex Manufacturing, Inc.FTA2025-08-02
05060792971242LITEXLitex Manufacturing, Inc.FTA2025-08-02
05060792971662LITEXLitex Manufacturing, Inc.FTA2025-08-02
00560792971716LITEXLitex Manufacturing, Inc.FTA2025-08-01
05060792970009LITEXLitex Manufacturing, Inc.FTA2025-08-01
05060792970016LitexLitex Manufacturing, Inc.FTA2025-08-01
05060792970023LITEXLitex Manufacturing, Inc.FTA2025-08-01
05060792970030LITEXLitex Manufacturing, Inc.FTA2025-08-01
05060792970047LitexLitex Manufacturing, Inc.FTA2025-08-01
05060792970054LITEXLitex Manufacturing, Inc.FTA2025-08-01