Identity
- Trade Name
- Merit Maestro® FDA UDI
- Generic Name
- Vascular microcatheter FDA UDI
- Model / Reference
- 00884450358009 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450358009 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
Yes
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
A comprehensive medical device designed for controlled infusion of fluids, diagnostic contrast media, and therapeutic devices into superselective small vessels. This single-use catheter is sterile, flexible, and features an ultrasound transducer, thermal sensor, and guidewire placement at its distal tip.
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 f1e3ebf7-8884-40eb-97c4-d63e7836966d 33 fields · synced Jul 24, 2026