FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450391218
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450391211
Catalog number
K12T-09931A
Published
2018-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10884450391218PackageGS18In Commercial Distribution
00884450391211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445039121810884450391218
00884450391211008844503912118844503912110884450391211

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
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
00884450079973Merit Medical®Initial ReleaseK09-10089M2026-06-09
00884450101537Merit Medical®Initial ReleaseK09-143202026-06-09
00884450101568Merit Medical®Initial ReleaseK09-143212026-06-09
00884450435748SCOUT®MSG-012026-06-09
00884450486962Merit Medical®Initial ReleaseK09-144042026-06-09
00884450486993Merit Medical®Initial ReleaseK10-062032026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450826560Fountain®BIS5-135-302026-06-09
10884450114008Prelude IDeal™HPID4F11018SS2026-06-09
10884450119799Prelude EASE™JPHR6F11021PW2026-06-09
00884450467572DuraMax®CH7871030281952026-06-08
00884450469033BioFlo DuraMax®BH9651030281612026-06-08
00884450469132BioFlo DuraMax®BH9651030282112026-06-08
00884450787663Impress®C44038STS2026-06-08
10884450114855Prelude IDeal™HPID5F16021PW2026-06-08
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956394261CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956406605CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956428300CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956452589CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956466395CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956469099CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956481947CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956483095CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956487284CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956494718CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956495586CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496118CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496231CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496521CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496637CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496682CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496811CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956498716CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956499362CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956499386CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956503526CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956504257CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956505223CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956409859CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05
10198956453708CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05
10198956460256CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05
10198956467262CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05
10198956488021CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05
10198956492868CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05
10198956493131CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-05