Identity
- Trade Name
- FENIX FDA UDI
- Generic Name
- Anal sphincter prosthesis FDA UDI
- Device Name
- FENIX Introducer FDA UDI
- Model / Reference
- FIT-2 FDA UDI
- Description
- FENIX Introducer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855106005448 FDA UDI
- PMA Number
- H130006 FDA UDI
- FDA Product Code
- PMH FDA UDI
- GMDN Term
- Anal sphincter prosthesis FDA UDI
Classification
- Device Class
- Unclassified FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Fenix by Torax Medical, Inc. — Class Unclassified — 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 Unclassified | Pending data |
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Manufacturer
- Manufacturer
- Torax Medical, Inc.
Sources (1)
- FDA UDI 06d1dded-8da4-479d-a741-689b02a09d91 35 fields · synced Jun 1, 2026