FDA.reportPublic FDA data

ACS

Primary DI
00191072033314
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
SMKN10Q
Device description
TOTAL KNEE PACK
Published
2018-09-24
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
00191072033314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072033314001910720333141910720333140191072033314

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
10809160528112HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528136HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528174HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528181HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528198HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528051HalyardAVID MEDICAL, INC.LRO2026-07-29
10809160528099HalyardAVID MEDICAL, INC.LRO2026-07-29
10653160393511CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-28
10809160527955HALYARDAVID MEDICAL, INC.LRO2026-07-28
10809160527962HALYARDAVID MEDICAL, INC.LRO2026-07-28
10809160527993HalyardAVID MEDICAL, INC.LRO2026-07-28
10809160528044HalyardAVID MEDICAL, INC.LRO2026-07-28
10197106838556CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956355385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956359512CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956371965CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956384927CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956390102CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956392885CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956393196CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956394735CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956400900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956401129CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956406544CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956410268CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956423817CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956443136CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956445758CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956445932CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956457829CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27