Identity
- Trade Name
- Torosa FDA UDI
- Generic Name
- Testicle prosthesis FDA UDI
- Device Name
- Saline Filled Testicular Prosthesis FDA UDI
- Model / Reference
- 450-1325 FDA UDI
- Description
- Saline Filled Testicular Prosthesis FDA UDI
Identifiers
- Catalog Number
- 450-1325 FDA UDI
- Primary DI / UDI-DI
- 05708932470810 FDA UDI
- PMA Number
- P020003 FDA UDI
- FDA Product Code
- FAF FDA UDI
- GMDN Term
- Testicle prosthesis FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 876.3750 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: Testicle prosthesis
Torosa by Coloplast A/S — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Testicle prosthesis.
- Torosa — Coloplast A/S · Class III
- Torosa — Coloplast A/S · Class III
- Torosa — Coloplast A/S · Class III
Cleared under the same submission
P020003 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI 498565fc-cb9f-407d-af24-eda1d6488d16 38 fields · synced Jun 1, 2026