FDA.reportPublic FDA data

ACS

Primary DI
00191072103376
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
ANST05C
Device description
BLOCK CENTER STERILE LABELS - 309080
Published
2020-04-06
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
LYVLABEL OR TAG, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYVLabel Or Tag, SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072103376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072103376001910721033761910721033760191072103376

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
10198459214035Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-22
10198459218194Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-22
10198459218309Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-22
10198459204401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-08
10198459205842Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-08
10198459189777Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-24
10198459166938Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-17
10198459181269Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-17
10198459159404Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-20
10198459148750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-13
10198459141454Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-06
10198459141546Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-06
10198459133381Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-29
10198459134517Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-29
10198459122712Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459122729Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459122736Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459115929Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119774Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119781Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119798Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459120725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459120732Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459109164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-08
10198459074493Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10198459075056Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10198459078750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10195327655099Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29
10195327668808Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29
10198459024825Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29