Identity
- Trade Name
- RIWO D-URS FDA UDI
- Generic Name
- Rigid video ureterorenoscope FDA UDI
- Device Name
- SENSOR-URETERORENOSCOPE 9FR WL 600MM flexible, working channel 1: 3,6FR, working channel 2: 1,65FR, PU= 3 pcs, sterile, for single use FDA UDI
- Model / Reference
- 473572076 FDA UDI
- Description
- SENSOR-URETERORENOSCOPE 9FR WL 600MM flexible, working channel 1: 3,6FR, working channel 2: 1,65FR, PU= 3 pcs, sterile, for single use FDA UDI
Identifiers
- Catalog Number
- 473572076 FDA UDI
- Primary DI / UDI-DI
- 04055207064177 FDA UDI
- 510(k) Number
- K201897 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Rigid video 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
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
Dimensions & Sizes
- Size
- Length — 600 Millimeter FDA UDIOuter Diameter — 3 Millimeter FDA UDI
Category: Rigid video ureterorenoscope
Riwo D-Urs by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid video ureterorenoscope.
- RIWO D-URS — Richard Wolf GmbH · Class II
Cleared under the same submission
K201897 also covers:
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
- Richard Wolf GmbH
Sources (1)
- FDA UDI 8292d003-822f-4b30-9dc2-5472364b52f2 38 fields · synced May 30, 2026