FDA.reportPublic FDA data

ACS

Primary DI
00191072096708
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
OSTR47A
Device description
TRAUMA PACK
Published
2020-02-03
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072096708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072096708001910720967081910720967080191072096708

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
10809160537855HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537862HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537879HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537886HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537893HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537909HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537916HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537923HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537930HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537947HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537954HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537961HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537985HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537992HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538005HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538029HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538036HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538043HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537541HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537558HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537572HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537589HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537596HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537602HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537640HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537664HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537688HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537695HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537701HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537732HalyardAVID MEDICAL, INC.LRO2026-09-19