FDA.reportPublic FDA data

ACS

Primary DI
00191072176455
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
GIOB37D
Device description
OB PACK
Published
2022-08-25
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
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072176455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072176455001910721764551910721764550191072176455

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
10198956359284CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956434547CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956436657CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956441958CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956445673CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956446649CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956457799CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956458000CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956465992CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956466036CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956467354CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956468092CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956473003CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956477155CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956477186CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956478466CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956480704CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956483156CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956484535CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956485327CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956486898CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956488625CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956489455CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10809160521786HalyardAVID MEDICAL, INC.OHD2026-05-22
50198956314687CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956374148CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956382433CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956399301CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956418194CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956425581CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24