FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450486306
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450486306
Catalog number
K12T-07556A
Published
2020-06-09
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450486306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450486306008844504863068844504863060884450486306

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

Regulatory Flags#

DUNS number
603160040
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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
00884450464991Merit 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