FDA.reportPublic FDA data

ACS

Primary DI
00191072125422
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
ROCS82B
Device description
C-SECTION
Published
2021-03-03
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
OHMCesarean Section Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072125422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072125422001910721254221910721254220191072125422

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
10080196943470Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2025-02-16
10080196887545Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-07-29
10193489212624Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489212686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489212914Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489216318Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489217025Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489214161Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2022-01-02
10193489290653Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2021-11-09
10193489291087Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2021-11-09
10193489291179Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2021-11-09
10193489292138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2021-11-09
10193489292190Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2021-11-09
10193489292251Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2021-11-09
10193489293180Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2021-11-09
10193489294057Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2021-11-09
10193489297300Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2021-11-09
10193489297607Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2021-11-09
10193489297676Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2021-11-09
10193489299663Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2021-11-09
10193489300376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2021-11-09
10193489301021Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2021-11-09
10193489301540Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2021-11-09
10193489301649Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2021-11-09
10193489301922Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2021-11-09
10193489302318Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2021-11-09
10193489302363Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2021-11-09
10193489303292Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2021-11-09
10193489303902Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2021-11-09
10193489303926Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2021-11-09