FDA.reportPublic FDA data

ACS

Primary DI
00191072241863
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
UIHN18AZ
Device description
HAND PACK (PS 020640)
Published
2026-02-19
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
00191072241863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072241863001910722418631910722418630191072241863

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
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
10809160543733HALYARDMEDICAL ACTION INDUSTRIES INC.OJH2026-11-04
10809160543757HALYARDMEDICAL ACTION INDUSTRIES INC.OJH2026-11-04
10809160543788HALYARDMEDICAL ACTION INDUSTRIES INC.OJH2026-11-04
10809160543795HALYARDMEDICAL ACTION INDUSTRIES INC.OJH2026-11-04
10198956569805CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956603806CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956603936CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956607811CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956612433CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956612556CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956615465CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956620728CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956620919CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956621183CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956621350CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956621640CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956623156CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956623330CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956624146CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956624276CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956624368CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956625358CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956625747CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956625846CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956626010CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
B098AMS18754A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-11-02
B098AMS18911A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-11-02
10809160542309HalyardAVID MEDICAL, INC.OJH2026-10-31
B098AMS14091A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-10-30
B098AMS200760Aligned Medical SolutionsAligned Medical SolutionsOJH2026-10-30