FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450464991
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K12T-12682
Published
2026-09-18
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
00884450464991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450464991008844504649918844504649910884450464991

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
00884450030301Merit Medical®Initial ReleaseK08-02374A2026-09-18
00884450101315Merit Medical®Initial ReleaseK12T-11002F2026-09-18
00884450121368Merit Medical®Initial ReleaseK04-00791B2026-09-19
00884450265260Merit Medical®Initial ReleaseK09T-10440D2026-09-18
00884450276808Merit Medical®Initial ReleaseK12T-084642026-09-18
00884450277164Merit Medical®Initial ReleaseK09T-09666F2026-09-18
00884450295854Merit Medical®Initial ReleaseK12T-094032026-09-18
00884450306628Merit Medical®Initial ReleaseK12T-02866A2026-09-18
00884450306635Merit Medical®Initial ReleaseK09T-10276A2026-09-18
00884450306642Merit Medical®Initial ReleaseK12T-03836A2026-09-18
00884450320150Merit Medical®Initial ReleaseK10T-052102026-09-18
00884450320426Merit Medical®Initial ReleaseK10T-053242026-09-18
00884450336922Merit Medical®Initial ReleaseK09T-115672026-09-18
00884450339589Merit Medical®Initial ReleaseK12T-031482026-09-18
00884450340011Merit Medical®Initial ReleaseK12T-035362026-09-18
00884450352069Merit Medical®Initial ReleaseK12T-078402026-09-18
00884450428443Merit Medical®Initial ReleaseK10-01694R2026-09-18
00884450428955Merit Medical®Initial ReleaseK09-14183A2026-09-18
00884450431740Merit Medical®Initial ReleaseK09-10388B2026-09-18
00884450432068Merit Medical®Initial ReleaseK09-07593C2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450101315Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450276808Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450295854Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450306628Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450306642Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450339589Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450340011Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450352069Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450441381Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450441589Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450470091Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450470909Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450485002Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450488829Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450533307Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450533321Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450533338Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450538920Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450612545Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450667729Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450772911Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450776544Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450780107Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450789926Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450795545Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450795569Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450802915Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450810910Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450812921Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18
00884450816301Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-18