Merit MAK Gold™ MAK510SSS

GUDID 10884450847289

Merit Medical Systems, Inc.

Vascular dilator, single-use
Primary Device ID10884450847289
NIH Device Record Keyd7f914f6-4223-45ce-8fad-d104bdcb81ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerit MAK Gold™
Version Model NumberInitial Release
Catalog NumberMAK510SSS
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS100884450847282 [Primary]
GS110884450847289 [Package]
Contains: 00884450847282
Package: [10 Units]
In Commercial Distribution

FDA Product Code

DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-21
Device Publish Date2025-07-11

On-Brand Devices [Merit MAK Gold™]

10884450847258Initial Release
10884450847241Initial Release
10884450846794Initial Release
10884450847289Initial Release

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