FDA.reportPublic FDA data

ACS

Primary DI
00191072087294
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
FRCS71X
Device description
C-SECTION TRAY
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
OHMCesarean section tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072087294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072087294001910720872941910720872940191072087294

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
10198956514461CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956556676CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956562288CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956570221CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956570412CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956499720CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956537279CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956537965CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956563636CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956524262CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-18
10198956556416CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-18
10198956554627CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-17
10198956510944CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956516243CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956538726CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956542303CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956360150CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956467965CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956481602CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956490017CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956508750CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956510067CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956519916CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956529274CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956531543CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956531918CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956533936CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956534179CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956534957CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956535381CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27