FDA.reportPublic FDA data

ACS

Primary DI
00191072235862
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
BRGY06U
Device description
GYN PACK
Published
2025-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00191072235862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072235862001910722358621910722358620191072235862

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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