Identity
- Trade Name
- TACTRA FDA UDI
- Generic Name
- Rigid penile prosthesis FDA UDI
- Device Name
- Malleable Penile Prosthesis FDA UDI
- Model / Reference
- 720081-01 FDA UDI
- Description
- Malleable Penile Prosthesis FDA UDI
Identifiers
- Catalog Number
- 720081-01 FDA UDI
- Primary DI / UDI-DI
- 08714729979357 FDA UDI
- FDA Product Code
- FAE FDA UDI
- GMDN Term
- Rigid penile prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.3630 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
MR Conditional FDA UDI
Category: Rigid penile prosthesis
Tactra by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid penile prosthesis.
- Genesis — Coloplast A/S · Class II
- RIGI10 — Rigicon, Inc. · Class II
- Spectra — AMERICAN MEDICAL SYSTEMS, INC. · Class II
- RIGI10 — Rigicon, Inc. · Class II
- Genesis — Coloplast A/S · Class II
- Genesis — Coloplast A/S · Class II
- TACTRA — Boston Scientific · Class II
- TACTRA — Boston Scientific · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 912d8082-98af-46ad-be3b-3bd208d68434 35 fields · synced Jun 8, 2026