FDA.reportPublic FDA data

LITEX

Primary DI
05060792971587
Brand
LITEX
Company
Litex Manufacturing, Inc.
Model
3660-ALM
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
05060792971587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060792971587050607929715875060792971587

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
16931918170732InvenioGRI Medical & Electronic Technology Co., Ltd.FTA2026-04-17
10748426144560Medline-MicrotekMicrotek Medical LLCFTA2026-02-18
00748426142934Skytron®Microtek Medical LLCFTA2026-02-05
00748426145027NAMicrotek Medical LLCFTA2026-02-05
20748426262704Medline-MicrotekMicrotek Medical LLCFTA2026-01-05
80080196761844MEDLINEMEDLINE INDUSTRIES, INC.FTA2025-11-04
10724995245457HexaLuxSTERIS CORPORATIONFTA2025-05-05
20885380184113CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184120CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184137CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
50885380184787CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
00724995203399NASTERIS CORPORATIONFTA2023-11-17
10197344006915MedlineMEDLINE INDUSTRIES, INC.FTA2023-11-05
16931918117362AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2023-07-20
16931918159256AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-26
16931918133201AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
16931918196565AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
00748426118526Skytron Lite-LokMicrotek Medical LLCFTA2022-08-08
10193489003093MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489003109MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489005875MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
00749756725538DeRoyalDEROYAL INDUSTRIES, INC.FTA2021-08-23
G018DLH010Physician's ChoiceSupply Line International Medical, LLCFTA2021-08-05
16931918155524AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918167046AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918173153AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918127309AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-03-08
16931918123493B.braunGRI Medical & Electronic Technology Co., Ltd.FTA2021-02-27
10885380121937CARDINAL HEALTHCardinal Health 200, LLCFTA2020-10-02
10885380121944CARDINAL HEALTHCardinal Health 200, LLCFTA2020-10-02