FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450486207
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K12T-12645C
Published
2026-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10884450486204PackageGS15In Commercial Distribution
00884450486207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445048620410884450486204
00884450486207008844504862078844504862070884450486207

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
603160040
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450117156Merit Medical®Initial ReleaseK12T-03663D2026-07-30
00884450486191Merit Medical®Initial ReleaseK12T-12644C2026-07-30
00884450498996Merit Medical®Initial ReleaseK09-143912026-07-30
00884450499207Merit Medical®Initial ReleaseK10T-01528J2026-07-30
00884450587713StabiliT®DDF-5000A2026-07-30
00884450022146One-Step™DOSC-4F-10LT2026-07-29
00884450022160One-Step™DOSC-4F-10T2026-07-29
00884450022184One-Step™DOSC-4F-7LT2026-07-29
00884450022306One-Step™DOSC-4F-7T2026-07-29
00884450022313One-Step™DOSC-5F-10LT2026-07-29
00884450022535One-Step™DOSC-5F-7LT2026-07-29
00884450022559One-Step™DOSC-5F-10S2026-07-29
00884450022566One-Step™DOSC-5F-7S2026-07-29
00884450022573One-Step™DOSC-4F-10L2026-07-29
00884450022597One-Step™DOSC-4F-10LNH2026-07-29
00884450022603One-Step™DOSC-4F-7L2026-07-29
00884450022665One-Step™DOSC-4F-7S2026-07-29
00884450022689One-Step™DOSC-5F-10LNH2026-07-29
00884450022764One-Step™DOSC-5F-7L2026-07-29
00884450024010One-Step™DOSC-5F-10T2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450117156Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450486191Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450487921Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-29
10198956323087CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956352377CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956353572CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956446816CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956474048CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956481350CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956489172CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956494527CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956505124CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956511309CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956512627CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956517196CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956517325CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956519213CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956521698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956523951CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956528796CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956528888CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956529045CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956529205CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956530522CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956530546CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956531246CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956531345CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956533387CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956533486CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956534209CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27