FDA.reportPublic FDA data

ACS

Primary DI
00191072241986
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
LKTH15W
Device description
TOTAL HIP
Published
2026-03-24
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
CodeName
OJHOrthopedic tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072241986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072241986001910722419861910722419860191072241986

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
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
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
00191072241924ACSIHAR39AH2026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956379084CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956421462CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956454989CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956468399CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956484795CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956505919CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956507678CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956507975CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956509061CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956509108CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956514423CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956519404CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956530003CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956530775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956533783CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956533844CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956538696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956544246CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956545137CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956545595CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956547612CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956551732CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956551756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956551770CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956552814CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956553668CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956553804CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956555259CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956555471CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956555648CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04