FDA.reportPublic FDA data

ACS

Primary DI
00191072117342
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
AGOB35D
Device description
AHN VAGINAL DELIVERY PACK 146336
Published
2020-10-08
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
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
00191072117342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072117342001910721173421910721173420191072117342

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
10198956589490CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-19
10198956606937CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-19
10198956609303CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-19
10198956606128CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-15
10198956588721CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-13
10198956537316CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956569072CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956587229CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956591394CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956594548CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956599154CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956599260CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956601000CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956542129CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-06
10198956569171CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-06
10198956559806CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-30
10198956544703CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-29
10198956514485CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956575363CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956585546CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956585553CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956543638CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956555372CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956563742CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956579675CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956504158CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956571648CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956571891CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956572966CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956549685CARDINAL HEALTHCardinal Health 200, LLCMLS2026-08-18