FDA.reportPublic FDA data

ACS

Primary DI
00191072164704
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
LSROSCMASTC
Device description
PACK MASTECTOMY OSC LH -2081662
Published
2022-05-02
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
FTNPlastic surgery and accessories kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTNPlastic Surgery And Accessories KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072164704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072164704001910721647041910721647040191072164704

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various 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
10080196920846Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2025-01-19
10193489425918Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-07-29
10193489434392Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-07-29
10193489214390Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489214475Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489215519Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489406696Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489414936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489416138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489416183Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489418828Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419399Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419450Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419597Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419726Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419733Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489421743Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489424171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489424850Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489426311Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489427073Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429114Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429299Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429305Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489439175Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489441352Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489441635Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489442670Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489442687Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08