Identity
- Trade Name
- Onyx 18 FDA UDI
- Generic Name
- Neurovascular embolization plug FDA UDI
- Device Name
- Liquid Embolic 105-7100-060 Onyx 18 FDA UDI
- Model / Reference
- 105-7100-060 FDA UDI
- Description
- Liquid Embolic 105-7100-060 Onyx 18 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00836462005044 FDA UDI
- PMA Number
- P030004 FDA UDI
- FDA Product Code
- MFE 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neurovascular embolization plug
Onyx 18 by Micro Therapeutics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurovascular embolization plug.
- TRUFILL — Cerenovus, Inc. · Class III
- TRUFILL — Cerenovus, Inc. · Class III
- TRUFILL — Cerenovus, Inc. · Class III
- TRUFILL — Cerenovus, Inc. · Class III
- ONYX 18 — Micro Therapeutics, Inc. · Class III
- Onyx HD 500 — Micro Therapeutics, Inc. · Unclassified
- ONYX 34 — Micro Therapeutics, Inc. · Class III
- Onyx 34 — Micro Therapeutics, Inc. · Class III
Cleared under the same submission
P030004 also covers:
- Apollo — Micro Therapeutics, Inc.
- Apollo — Micro Therapeutics, Inc.
- Apollo Onyx — Micro Therapeutics, Inc.
- Apollo Onyx — Micro Therapeutics, Inc.
- ApolloTM — Micro Therapeutics, Inc.
- ApolloTM — Micro Therapeutics, Inc.
- ONYX 18 — Micro Therapeutics, Inc.
- ONYX 34 — Micro Therapeutics, Inc.
- Onyx 34 — Micro Therapeutics, Inc.
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
- Micro Therapeutics, Inc.
Sources (1)
- FDA UDI 81f0bad3-88db-4089-b278-8ac01f509af6 36 fields · synced Jun 1, 2026