FDA.reportPublic FDA data

ACS

Primary DI
00191072149756
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
LAMP04AA
Device description
MAJOR PLASTICS PACK
Published
2021-10-14
Public version status
New
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
FTNPlastic surgery and accessories kit

Product Code Classifications

CodeDeviceSpecialtyClass
FTNPlastic Surgery And Accessories KitGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191072149756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072149756001910721497561910721497560191072149756

GMDN Terms

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
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
40198459454678MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459454814MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459460686MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459462475MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459469887MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459469894MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
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40198459471019MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459472610MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459473761MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459473792MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459473945MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459474454MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459474560MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459475925MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459479671MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459479688MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-18
40198459443276MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459444518MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459450557MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459450564MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459453473MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459455590MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459455682MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459456344MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459457334MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459460297MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459463854MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459464523MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11
40198459466398MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FTN2025-08-11