Identity
- Trade Name
- Merit Maestro® FDA UDI
- Generic Name
- Vascular microcatheter FDA UDI
- Model / Reference
- 00884450335239 FDA UDI
Identifiers
- Catalog Number
- 28MC21110ST/B FDA UDI
- Primary DI / UDI-DI
- 00884450335239 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular microcatheter
The Merit Maestro catheter is a sterile, small-diameter, single-lumen flexible tube designed for the controlled infusion of fluids into superselective small vessels for angiography and treatment, and delivery of devices. It features an ultrasound transducer, thermal sensor, and distal tip guidewire placement.
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 e9a970b5-de6f-4c1e-8073-1946bf96012f 34 fields · synced Jul 18, 2026