FDA.reportPublic FDA data

ACS

Primary DI
00191072084446
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
BHLH43I
Device description
PELVISCOPY
Published
2020-05-11
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
OHDGynecological laparoscopic kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072084446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072084446001910720844461910720844460191072084446

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
10198956313576CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956333888CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956428003CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956467446CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956484467CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956485150CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956492349CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956497634CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956497672CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956504950CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956505773CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956509290CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956515543CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956525054CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956527423CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956528079CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956477001CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956505612CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956509344CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956525184CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956526747CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956318595CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956488496CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956510227CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956511088CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956515253CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956436626CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956465176CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956467651CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956488922CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08