Identity
- Trade Name
- TRUFILL FDA UDI
- Generic Name
- Neurovascular embolization plug FDA UDI
- Device Name
- TRUFILL n-BCA Liquid Embolic System Procedural Set Contents: 1 g n-BCA, self-piercing cap, 1 g Ta Powder, 10 mL Ethiodized Oil, (3) 1 mL and (3) 3 mL syringes, 30 mL beaker, 18 G blunt fill needle, (2) 21 G hypodermic needles, syringe labels FDA UDI
- Model / Reference
- 632500NA FDA UDI
- Description
- TRUFILL n-BCA Liquid Embolic System Procedural Set Contents: 1 g n-BCA, self-piercing cap, 1 g Ta Powder, 10 mL Ethiodized Oil, (3) 1 mL and (3) 3 mL syringes, 30 mL beaker, 18 G blunt fill needle, (2) 21 G hypodermic needles, syringe labels FDA UDI
Identifiers
- Catalog Number
- 632500NA FDA UDI
- Primary DI / UDI-DI
- 10886704085317 FDA UDI
- PMA Number
- P990040 FDA UDI
- FDA Product Code
- KGG FDA UDI
- GMDN Term
- Neurovascular embolization plug FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Category: Neurovascular embolization plug
Trufill by Cerenovus, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- TRUFILL — Cerenovus, Inc. · Class III
- TRUFILL — Cerenovus, Inc. · Class III
- TRUFILL — Cerenovus, Inc. · Class III
Cleared under the same submission
P990040 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Cerenovus, Inc.
Sources (1)
- FDA UDI d50bc440-2751-4d7d-a8cc-8544081eef69 36 fields · synced Jun 1, 2026