Identity
- Trade Name
- DUOROTATE FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- SHEATH TUBE INSULATED Ø 5.8MM SL 380MM distal curved, Compatible with all DUORotate and InLine inserts, along with DUORotate and InLine handles, reusable FDA UDI
- Model / Reference
- 8399310 FDA UDI
- Description
- SHEATH TUBE INSULATED Ø 5.8MM SL 380MM distal curved, Compatible with all DUORotate and InLine inserts, along with DUORotate and InLine handles, reusable FDA UDI
Identifiers
- Catalog Number
- 8399310 FDA UDI
- Primary DI / UDI-DI
- 04055207016930 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 380 Millimeter FDA UDIOuter Diameter — 5.8 Millimeter FDA UDI
Duorotate by Richard Wolf GmbH — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
Sources (1)
- FDA UDI e5e4bb04-52c2-4fd3-8ee2-bf779796bdee 37 fields · synced Jun 8, 2026