Merit MAK Gold™ MAK511PTE

GUDID 10884450847241

Merit Medical Systems, Inc.

Vascular dilator, single-use
Primary Device ID10884450847241
NIH Device Record Keyc056f1d7-a966-4e59-8a19-3c9cdc3787f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerit MAK Gold™
Version Model NumberInitial Release
Catalog NumberMAK511PTE
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
GS100884450847244 [Primary]
GS110884450847241 [Package]
Contains: 00884450847244
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 Date2025-05-21
Device Publish Date2025-05-13

On-Brand Devices [Merit MAK Gold™]

10884450847258Initial Release
10884450847241Initial Release

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