FDA.reportPublic FDA data

ACS

Primary DI
00191072226792
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
AGRO47O
Device description
AHN GYNE ROBOTIC 156958
Published
2024-07-22
Public version status
New
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
FDElaparoscopy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072226792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072226792001910722267921910722267920191072226792

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10080196887248Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2025-01-19
10080196926213Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2025-01-19
10193489213928Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2024-07-29
10080196498192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-07-29
10080196498345Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-07-29
10193489211658Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489212594Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489213003Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489213515Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489214116Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489214154Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489215472Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489216769Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489287592Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489288285Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489288407Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489288414Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489289732Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489289749Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489289848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489290059Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489290189Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489290196Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489290240Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489291049Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489291100Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489291155Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489291902Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489292114Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489292121Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09