FDA.reportPublic FDA data

ACS

Primary DI
00191072203373
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
UHEX80AF
Device description
EXTREMITY PACK - 206079
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00191072203373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072203373001910722033731910722033730191072203373

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
10198956056497CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956221161CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956253773CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956257610CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956291812CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956321632CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956325487CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956354517CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956358904CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956369955CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956379190CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956379381CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956382763CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956387492CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956387799CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956392465CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956399464CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956400818CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956401136CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956404151CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956414891CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956425811CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956432987CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956434752CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956437869CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956442351CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956442634CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956448339CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956457980CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956457997CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25