FDA.reportPublic FDA data

ACS

Primary DI
00191072125149
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
RWOB72H
Device description
VAG DELIVERY--LF
Published
2021-09-02
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
00191072125149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072125149001910721251491910721251490191072125149

GMDN Terms#

Term, Definition table
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 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
10198956449114CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956453258CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956472501CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956476196CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956488663CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956488700CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
50198956420531CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-24
50198956421040CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-24
50198956417753CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956419818CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956420548CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956420760CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956427820CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956310092CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956393774CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956407365CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956408805CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956413946CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956318609CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956401363CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956414950CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956418774CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956278064CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956313925CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956408706CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956408959CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411416CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411485CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411775CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956366099CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-09