Home GUDID 00191072174222 ACS
Primary DI 00191072174222
Brand ACS
Company AMERICAN CONTRACT SYSTEMS, INC.
Model JEPC04N
Device description PACER ICD
Published 2022-08-25
Public version status New
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 OEZ Cardiovascular procedure kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OEZ Cardiovascular Procedure Kit Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00191072174222 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 00191072174222 00191072174222 191072174222 0191072174222
GMDN Terms# Term, Definition table Term Definition General surgical procedure kit, non-medicated, single-use A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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 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 H65857029425 Henry Schein HENRY SCHEIN, INC. OEZ 2022-03-31 H65857029535 Henry Schein HENRY SCHEIN, INC. OEZ 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 10193489040302 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040319 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040326 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040333 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040340 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040357 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040364 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040371 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040388 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040395 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28 10193489040401 NAMIC MEDLINE INDUSTRIES, INC. OEZ 2021-10-28