Identity
- Trade Name
- Prostiva Hand Piece FDA UDI
- Generic Name
- Rigid optical cystoscope FDA UDI
- Device Name
- Prostiva RF Therapy Hand Piece FDA UDI
- Model / Reference
- 8929 FDA UDI
- Description
- Prostiva RF Therapy Hand Piece FDA UDI
Identifiers
- Primary DI / UDI-DI
- M87689290 FDA UDI
- 510(k) Number
- K113380 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Rigid optical cystoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-useRigid optical cystoscopeElectrosurgical return electrode, single-use, sterileUrological irrigation set
Prostiva Hand Piece by Urologix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Urologix, Inc.
Sources (1)
- FDA UDI 606b15c2-08ef-45fe-9576-3f209940c272 36 fields · synced May 30, 2026