Identity
- Trade Name
- FENIX FDA UDI
- Generic Name
- Anal sphincter prosthesis FDA UDI
- Model / Reference
- FXS-[18] FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855106005516 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
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
MR Unsafe 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 1c647612-bdbf-40a9-b8e3-ee1dfd716145 34 fields · synced Jun 1, 2026