FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450844257
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K12-08323A
Published
2024-12-21
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
10884450844257PackageGS110In Commercial Distribution
20884450844254PackageGS124In Commercial Distribution
00884450844250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445084425710884450844257
2088445084425420884450844254
00884450844250008844508442508844508442500884450844250

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
184763290
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
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