Identity
- Trade Name
- TRUFILL FDA UDI
- Generic Name
- Neurovascular embolization coil FDA UDI
- Device Name
- TRUFILL Pushable Coils 5 Vascular Occlusion Devices Compatibality (Microcatheter) 0.21 Inch ID (.5 mm) Length in Introducer 6 mm 3 mm FDA UDI
- Model / Reference
- 633-120 FDA UDI
- Description
- TRUFILL Pushable Coils 5 Vascular Occlusion Devices Compatibality (Microcatheter) 0.21 Inch ID (.5 mm) Length in Introducer 6 mm 3 mm FDA UDI
Identifiers
- Catalog Number
- 633120 FDA UDI
- Primary DI / UDI-DI
- 10886704029212 FDA UDI
- 510(k) Number
- K123560 FDA UDI
- FDA Product Code
- HCG FDA UDI
- GMDN Term
- Neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5950 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Trufill by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cerenovus, Inc.
Sources (1)
- FDA UDI 6a3a9273-da79-4512-bb09-b0908f3afbc5 38 fields · synced May 30, 2026