Identity
- Trade Name
- AMS 700™ CX TENACIO™ Pump FDA UDI
- Generic Name
- Inflatable penile prosthesis FDA UDI
- Device Name
- Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal FDA UDI
- Model / Reference
- 72404434 FDA UDI
- Description
- Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal FDA UDI
Identifiers
- Catalog Number
- 72404434 FDA UDI
- Primary DI / UDI-DI
- 00191506021351 FDA UDI
- FDA Product Code
- JCW FDA UDI
- GMDN Term
- Inflatable penile prosthesis FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 876.3350 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
Yes
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
Dimensions & Sizes
- Size
- Length — 24 Centimeter FDA UDI
Category: Inflatable penile prosthesis
AMS 700™ CX TENACIO™ Pump by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inflatable penile prosthesis.
- Titan — Coloplast A/S · Class III
- Titan — Coloplast A/S · Class III
- Titan — Coloplast A/S · Class III
- Titan — Coloplast A/S · Class III
- Titan Classic — Coloplast A/S · Class III
- Titan® — Coloplast A/S · Class III
- Titan — Coloplast A/S · Class III
- Titan — Coloplast A/S · Class III
Cleared under the same submission
N970012 also covers:
- AMS 700 Accessory Kit — Boston Scientific
- AMS 700 CX — Boston Scientific
- AMS 700 CX — Boston Scientific
- AMS 700 CX — Boston Scientific
- AMS 700 CX — Boston Scientific
- AMS 700 CX — Boston Scientific
- AMS 700 CX MS Pump — Boston Scientific
- AMS 700 CX MS Pump — Boston Scientific
- AMS 700 CX MS Pump — Boston Scientific
- AMS 700 CX MS Pump — Boston Scientific
- AMS 700 CX MS Pump — Boston Scientific
- AMS 700 CX MS Pump — Boston Scientific
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
- Boston Scientific
Sources (1)
- FDA UDI 7ecade2a-9540-4a64-9dfe-8d9c8707599d 36 fields · synced Jun 8, 2026