Identity
- Trade Name
- Merit Maestro® FDA UDI
- Generic Name
- Vascular microcatheter FDA UDI
- Model / Reference
- 00884450315996 FDA UDI
Identifiers
- Catalog Number
- 28MC24150SN-I FDA UDI
- Primary DI / UDI-DI
- 00884450315996 FDA UDI
- FDA Product Code
- OJV FDA UDI
- GMDN Term
- Vascular microcatheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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 vascular microcatheter is a single-use, sterile device designed for controlled infusion of fluids into small vessels. It features a flexible design with a guide wire configuration, an ultrasound transducer, and a thermal sensor.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 9e223aad-327a-479d-b969-011cdfe88336 34 fields · synced Jul 12, 2026