FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450707357
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450707357
Catalog number
K12T-12327
Published
2022-11-04
Public version status
New
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
00884450707357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450707357008844507073578844507073570884450707357

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.

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
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
00884450392928SCOUT MD™Initial ReleaseMDS10M-012026-05-21
00884450394427SCOUT MD™Initial ReleaseMDS75SB-012026-05-21
00884450399170SCOUT MD™Initial ReleaseMDS75SC-012026-05-21
00884450436066Merit Medical®Initial ReleaseK08-02870A2026-05-21
00884450436172Merit Medical®Initial ReleaseK09-14009A2026-05-21
00884450122679Merit Medical®Initial ReleaseK08-02092B2026-05-20
00884450180075Merit Medical®Initial ReleaseK09-13303A2026-05-20
00884450424636Merit Medical®Initial ReleaseK09-13719B2026-05-20
00884450437988Merit Disposal Depot™Initial ReleaseK10-00577B2026-05-20

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