Merit MAK Gold™ MAK411PTE

GUDID 10884450847258

Merit Medical Systems, Inc.

Vascular dilator, single-use

Primary Device ID	10884450847258
NIH Device Record Key	6d87bb1b-73e7-4313-8652-652fe9d3751e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Merit MAK Gold™
Version Model Number	Initial Release
Catalog Number	MAK411PTE
Company DUNS	184763290
Company Name	Merit Medical Systems, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450847251 [Primary]
GS1	10884450847258 [Package] Contains: 00884450847251 Package: [10 Units] In Commercial Distribution

FDA Product Code

DRE	DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2025-05-21
Device Publish Date	2025-05-13

On-Brand Devices [Merit MAK Gold™]

10884450847258	Initial Release
10884450847241	Initial Release