FDA.reportPublic FDA data

ACS

Primary DI
00191072027146
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
FRTK62V
Device description
TOTAL KNEE PACK
Published
2020-05-12
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
00191072027146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072027146001910720271461910720271460191072027146

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
05060267134547FORCECORDXIROS LTDOJH2026-07-06
10198956182004CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956373068CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956407053CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956414693CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956428881CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956429901CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956457775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956474895CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956481015CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956484177CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956490833CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956491038CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956492158CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956492196CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956494572CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956494695CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956497498CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956498426CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956498471CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956499775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956503199CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956503298CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956508798CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956509368CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956512962CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956513921CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956516571CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956518018CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956525597CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06