FDA.reportPublic FDA data

ACS

Primary DI
00191072078513
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
ICAR87G
Device description
ARTHROSCOPY PACK
Published
2019-09-16
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
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072078513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072078513001910720785131910720785130191072078513

GMDN Terms#

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

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
10198956333901CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956530645CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956537262CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956539563CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956542631CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956558915CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956559608CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956560147CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956562592CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956562967CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956563018CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956566880CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567467CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567771CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956568976CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956569256CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956570894CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956570900CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956571549CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956580091CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956582941CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956587373CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956592353CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956592735CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956592865CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956593695CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956596443CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956356122CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-29
10198956474888CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-29