Merit Maestro®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: Merit Maestro® FDA UDI
Generic Name: Vascular microcatheter FDA UDI
Model / Reference: 00884450013984 FDA UDI

Identifiers

Catalog Number: 28MC2815045/B FDA UDI
Primary DI / UDI-DI: 00884450013984 FDA UDI
FDA Product Code: KRA FDA UDI
GMDN Term: Vascular microcatheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1210 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Vascular microcatheter

A sterile, small-diameter, single-lumen flexible tube for controlled infusion of fluids into superselective small vessels for angiography/treatment and device delivery. This is a single-use implantable medical device.

Similar devices

Also classified as Vascular microcatheter.

Velocity Delivery Microcatheter — PENUMBRA, INC. · Class II
Knight Microcatheter — ZIEN Medical Technologies, LLC · Class II
Renegade™ HI-FLO™ Kit — Boston Scientific · Class II
PROWLER — Medos International Sàrl · Class II
Lantern Delivery Catheter — PENUMBRA, INC. · Class II
Direxion™ Fathom™-16 System — Boston Scientific · Class II
Direxion™ — Boston Scientific · Class II
SUPERCROSS — TELEFLEX INCORPORATED · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Merit Medical Systems, Inc.

Sources (1)

FDA UDI b25ee36c-872b-4eff-9cb8-628cae4e6d32 34 fields · synced Jul 22, 2026