Identity
- Trade Name
- Deactivation Package FDA UDI
- Generic Name
- Urethral sphincter prosthesis, non-powered FDA UDI
- Device Name
- 3 Tubing Plugs, 1 Straight Connector FDA UDI
- Model / Reference
- 72400095 FDA UDI
- Description
- 3 Tubing Plugs, 1 Straight Connector FDA UDI
Identifiers
- Catalog Number
- 72400095 FDA UDI
- Primary DI / UDI-DI
- 00878953000664 FDA UDI
- FDA Product Code
- QGA FDA UDIQGD FDA UDI
- GMDN Term
- Urethral sphincter prosthesis, non-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.3500 FDA UDI876.5290 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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: Urethral sphincter prosthesis, non-powered
Deactivation Package by Boston Scientific — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urethral sphincter prosthesis, non-powered.
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- AMS 800 Artificial Urinary Sphincter — Boston Scientific · Class III
- AMS 800 Artificial Urinary Sphincter — Boston Scientific · Class III
- AMS 800 Artificial Urinary Sphincter — Boston Scientific · Class III
- AMS 800 Artificial Urinary Sphincter — Boston Scientific · Class III
- AMS 800 Artificial Urinary Sphincter — Boston Scientific · Class III
- AMS 800 Artificial Urinary Sphincter — Boston Scientific · Class III
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 I | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI f526e221-e0d5-4851-9cf0-32b2a0c33480 34 fields · synced Jun 7, 2026