Identity
- Trade Name
- FIBER URETEROSCOPE FDA UDI
- Generic Name
- Flexible fibreoptic ureterorenoscope FDA UDI
- Device Name
- FIBEROPTICURETEROSCOPE1.2C 3.0TP 700 ROP (USED) FDA UDI
- Model / Reference
- FUR-9RBS FDA UDI
- Description
- FIBEROPTICURETEROSCOPE1.2C 3.0TP 700 ROP (USED) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333240340 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Flexible fibreoptic ureterorenoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible fibreoptic ureterorenoscope
Fiber Ureteroscope by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic ureterorenoscope.
- Flex-X — Karl Storz GmbH & Co. KG · Class II
- COBRA — Richard Wolf GmbH · Class II
- PENTAX — HOYA CORPORATION · Class II
- Flex-X — Karl Storz GmbH & Co. KG · Class II
- URETERO-RENO FIBERSCOPE — Olympus Medical Systems Corporation · Class II
- URETERO-RENO FIBERSCOPE — Olympus Medical Systems Corporation · Class II
- VIPER — Richard Wolf GmbH · Class II
- URETERO-RENO FIBERSCOPE — Olympus Medical Systems Corporation · 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
- PENTAX of America, Inc.
Sources (1)
- FDA UDI 359577aa-0e69-4566-9162-1919b92e5ab7 33 fields · synced Jun 1, 2026