FDA.reportPublic FDA data

ACS

Primary DI
00191072129994
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
IHEP07P
Device description
EP PK
Published
2021-04-07
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
OEQAngiography/angioplasty kit
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072129994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072129994001910721299941910721299940191072129994

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
10198956587298CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-01
10809160539569HalyardAVID MEDICAL, INC.OEZ2026-10-01
10197106980361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956485105CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956509702CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956551589CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956553583CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956563247CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956565913CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956568167CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956575745CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956578999CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956581593CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956581661CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956588820CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956589209CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956590083CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592285CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592575CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956592599CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592636CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592681CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956592704CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592810CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956593688CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956593961CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956594623CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956595255CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956596078CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956596153CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30