Identity
- Trade Name
- AMS 800 Artificial Urinary Sphincter FDA UDI
- Generic Name
- Urethral sphincter prosthesis, non-powered FDA UDI
- Device Name
- Pressure Regulating Balloon, Pressure: 41-50 cm H20 FDA UDI
- Model / Reference
- 72400022 FDA UDI
- Description
- Pressure Regulating Balloon, Pressure: 41-50 cm H20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00878953000602 FDA UDI
- FDA Product Code
- EZY FDA UDI
- GMDN Term
- Urethral sphincter prosthesis, non-powered FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 876.5280 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
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 50 Centimeter FDA UDI
AMS 800 Artificial Urinary Sphincter by American Medical Systems, Inc. — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- American Medical Systems, Inc.
Sources (1)
- FDA UDI ec84568f-6453-4456-b76e-e3d377332280 35 fields · synced May 30, 2026