FDA.report

Merit MAK Gold™

Primary DI
10884450847265
Brand
Merit MAK Gold™
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
MAK410SSS
Published
2025-08-05
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

Related Records

Product Codes

CodeName
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications

CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450847265PackageGS110In Commercial Distribution
00884450847268PrimaryGS10

GMDN Terms

TermDefinition
Vascular dilator, single-useA sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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

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