FDA.reportPublic FDA data

ACS

Primary DI
00191072116017
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
TPIR15C
Device description
IR/CATH LAB PACK 176505
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072116017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072116017001910721160171910721160170191072116017

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
10198956378254CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956421394CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956422308CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956460485CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956466968CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956473164CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956484542CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486478CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486669CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486768CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956488267CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956490567CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
00884450474587Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-23
00884450220696Merit Medical®Merit Medical Systems, Inc.OEQ2026-03-24
50198956300499CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956339840CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956418514CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956421804CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956431957CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956274721CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956325331CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956332872CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956337969CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956339918CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956341508CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956343342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956346541CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956353211CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956353488CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956359466CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23