Identity
- Trade Name
- HydroFrame 10 Advanced FDA UDI
- Generic Name
- Neurovascular embolization coil FDA UDI
- Device Name
- V-Trak FDA UDI
- Model / Reference
- 7110-1036 FDA UDI
- Description
- V-Trak FDA UDI
Identifiers
- Catalog Number
- 7110-1036 FDA UDI
- Primary DI / UDI-DI
- 00812636020396 FDA UDI
- FDA Product Code
- KRD FDA UDI
- GMDN Term
- Neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
MR Conditional FDA UDI
Category: Neurovascular embolization coil
HydroFrame 10 Advanced by Microvention Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurovascular embolization coil.
- Target — Stryker Corp. · Class II
- Axium PrimeTM — Micro Therapeutics, Inc. · Class II
- AxiumTM — Micro Therapeutics, Inc. · Class II
- WEB Aneurysm Embolization System — SEQUENT MEDICAL, INC. · Class III
- TARGET — Stryker Corp. · Class II
- Axium™ Prime Detachable Coil System — Micro Therapeutics, Inc. · Class II
- Axium™ Prime Detachable Coil System — Micro Therapeutics, Inc. · Class II
- AxiumTM — Micro Therapeutics, Inc. · 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
- Microvention Inc.
Sources (1)
- FDA UDI 09a2f9ba-896e-4dcb-a2a9-0aa5edfbbfba 36 fields · synced May 31, 2026