FDA.report

ACS

Primary DI
00191072020604
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
SCAR05G
Device description
ARTHROSCOPY PACK
Published
2018-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LROGeneral surgery tray
OJHOrthopedic Tray

Product Code Classifications

CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191072020604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072020604001910720206041910720206040191072020604

GMDN Terms

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
Ethylene Oxide

Regulatory Flags

DUNS number
010334675
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
00191072241979ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072241986ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072241993ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242006ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242013ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242020ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00869397000013XL Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000020Radiolucent Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000037Standard Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000044Removal System Instrument SetSi-Bone Inc.OJH2026-03-24
008693970000517.5mm & 10.75mm Instrument SetSi-Bone Inc.OJH2026-03-24
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50198956302929CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956306866CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956307986CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956308006CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956327939CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956334760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956357981CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956359893CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956360530CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956362015CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956366372CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956372472CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956377804CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956379167CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956379211CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956382150CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24