FDA.reportPublic FDA data

ACS

Primary DI
00191072224019
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
AKDV96B
Device description
VAGINAL DELIVERY
Published
2024-05-08
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
MLSLabor and Delivery Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLSLabor And Delivery KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072224019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072224019001910722240191910722240190191072224019

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
10193489215052Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489215649Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489410006Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489412673Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489414646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489415773Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489417289Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489418187Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419214Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419290Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419429Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489423730Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489424089Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489426229Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489426410Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489430202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489443288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489446159Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489447286Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489454598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489454666Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489455946Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489456899Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489459319Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10080196849710Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-11-24
10193489420562Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-11-24
10193489426274Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-08-04
10193489431551Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-01-16
10193489451238Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-01-02
10193489457896Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-01-02