FDA.reportPublic FDA data

ACS

Primary DI
00191072064080
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
FBHC45G
Device description
HEART CATHETERIZATION TRAY 152749
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072064080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072064080001910720640801910720640800191072064080

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
B098DDS1159D0Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-26
10198459754210MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459754524MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755699MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755705MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459758287MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459758294MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459759291MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459761850MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459766336MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459771224MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459774126MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775437MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775666MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775673MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775680MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459778827MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459779985MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459784996MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459786808MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459787690MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459788130MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459789717MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459789724MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459791994MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459792007MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459795138MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459796975MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459799143MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459809187MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25