Identity
- Trade Name
- Direxion™ FDA UDI
- Generic Name
- Vascular microcatheter FDA UDI
- Device Name
- Torqueable Microcatheter FDA UDI
- Model / Reference
- M001195250 FDA UDI
- Description
- Torqueable Microcatheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729839361 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
Yes
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
Direxion™ by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Lantern Delivery Catheter — PENUMBRA, INC. · Class II
- SUPERCROSS — TELEFLEX INCORPORATED · Class II
- Merit Maestro® — Merit Medical Systems, Inc. · Class I
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
- Boston Scientific
Sources (1)
- FDA UDI ece3f9a5-bbb4-40c5-a64e-ab4ec4e579a7 34 fields · synced May 30, 2026