FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450587119
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450587119
Catalog number
K12T-05327C
Published
2021-08-03
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
00884450587119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450587119008844505871198844505871190884450587119

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various 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
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
10193489078114NAMICMEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489078213NAMICMEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489078220NAMICMEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489213430Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489410013Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489413458Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489423372Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489424003Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489425147Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489433111Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489448917Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489449198Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489453645Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489455885Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489456172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489458121Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489037517MEDLINEMEDLINE INDUSTRIES, INC.OEQ2023-05-30
10193489037524MEDLINEMEDLINE INDUSTRIES, INC.OEQ2023-05-30
10193489037531MEDLINEMEDLINE INDUSTRIES, INC.OEQ2023-05-30
10193489037548MEDLINEMEDLINE INDUSTRIES, INC.OEQ2023-05-30
10193489037555MedlineMEDLINE INDUSTRIES, INC.OEQ2023-05-30
H65857032425Henry ScheinHENRY SCHEIN, INC.OEQ2023-01-10
10193489444551Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-09-04
10193489078121NAMICMEDLINE INDUSTRIES, INC.OEQ2022-08-04
10193489248760Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-08-04
10193489665727Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-08-04
10193489457223Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-07-24
10193489461534Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-06-11
H65857029605Henry ScheinHENRY SCHEIN, INC.OEQ2022-04-05
H65857029435Henry ScheinHENRY SCHEIN, INC.OEQ2022-03-31