Home GUDID 00191072111005 ACS
Primary DI 00191072111005
Brand ACS
Company AMERICAN CONTRACT SYSTEMS, INC.
Model LKEP42I
Device description EP PACK
Published 2020-04-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name OEQ Angiography/angioplasty kit OEZ Cardiovascular Procedure Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OEQ Angiography/Angioplasty Kit Cardiovascular 2 OEZ Cardiovascular Procedure Kit Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00191072111005 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00191072111005 00191072111005 191072111005 0191072111005
GMDN Terms# Term, Definition table Term Definition General/plastic surgical procedure kit, non-medicated, single-use A collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 010334675 Device count 1 Premarket exempt true Kit true Lot or batch true Serial number true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10809160521984 Halyard AVID MEDICAL, INC. OEZ 2026-05-27 10809160522035 HALYARD AVID MEDICAL, INC. OEQ 2026-05-27 10193489037517 MEDLINE MEDLINE INDUSTRIES, INC. OEQ 2023-05-30 10193489037524 MEDLINE MEDLINE INDUSTRIES, INC. OEQ 2023-05-30 10193489037531 MEDLINE MEDLINE INDUSTRIES, INC. OEQ 2023-05-30 10193489037548 MEDLINE MEDLINE INDUSTRIES, INC. OEQ 2023-05-30 10193489037555 Medline MEDLINE INDUSTRIES, INC. OEQ 2023-05-30 H65857032425 Henry Schein HENRY SCHEIN, INC. OEQ 2023-01-10 H65857031555 Henry Schein HENRY SCHEIN, INC. OEZ 2022-08-25 H65857031565 Henry Schein HENRY SCHEIN, INC. OEZ 2022-08-25 H65857031315 Henry Schein HENRY SCHEIN, INC. OEZ 2022-08-10 H65857030865 Henry Schein HENRY SCHEIN, INC. OEZ 2022-05-25 H65857029605 Henry Schein HENRY SCHEIN, INC. OEQ 2022-04-05 H65857029425 Henry Schein HENRY SCHEIN, INC. OEZ 2022-03-31 H65857029435 Henry Schein HENRY SCHEIN, INC. OEQ 2022-03-31 H65857029535 Henry Schein HENRY SCHEIN, INC. OEZ 2022-03-31 H65857029585 Henry Schein HENRY SCHEIN, INC. OEQ 2022-03-31 10193489040166 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040180 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040197 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040203 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040210 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040227 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040234 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040241 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040258 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040265 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040272 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040289 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040296 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28