FDA.reportPublic FDA data

ACS

Primary DI
00191072062321
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
HWKA04Q
Device description
KNEE ARTHROSCOPY
Published
2020-07-15
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
00191072062321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072062321001910720623211910720623210191072062321

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
10198956225992CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956269323CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956321441CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956334670CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956360716CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956361461CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956372054CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956372498CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956378964CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956379176CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956388031CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956391253CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956392205CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956395206CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956396913CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956398511CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956409774CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956409880CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956421912CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956424166CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956427167CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956435506CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956437845CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956439184CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956440906CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956445659CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956457782CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956459922CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956463066CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956463080CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01