FDA.reportPublic FDA data

ACS

Primary DI
00191072160287
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
CEMJ08J
Device description
MAJOR PACK
Published
2022-02-05
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
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072160287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072160287001910721602871910721602870191072160287

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various 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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191072241948ACSAMMV04AE2026-03-24
00191072241962ACSFDCR00AE2026-03-24
00191072241979ACSLKTK16AB2026-03-24
00191072241986ACSLKTH15W2026-03-24
00191072241993ACSFDTH08AJ2026-03-24
00191072242006ACSFDTK07AH2026-03-24
00191072242013ACSFDKA44S2026-03-24
00191072242020ACSFDSA15N2026-03-24
00191072242037ACSBPHA89E2026-03-24
00191072241757ACSSPSA58S2026-02-19
00191072241764ACSLLGT12F2026-02-19
00191072241801ACSCIEY01G2026-02-19
00191072241818ACSWEHF12B2026-02-19
00191072241856ACSRGLC12P2026-02-19
00191072241863ACSUIHN18AZ2026-02-19
00191072241870ACSBDAG39C2026-02-19
00191072241887ACSIHTK48AO2026-02-19
00191072241894ACSIHTR90N2026-02-19
00191072241900ACSUICA66AS2026-02-19
00191072241917ACSMWTK13AI2026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815849020917Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022768Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022775Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022782Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022836Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849025288Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849025493Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849025844Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
10198956371019CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956474987CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956504172CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956518629CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956520080CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956534520CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956535237CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956538375CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956539761CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956547322CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956549982CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956554016CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956555570CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956561281CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956565838CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956569959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956570849CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956575035CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956575288CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956582842CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956583061CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956586482CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06