Identity
- Trade Name
- SHARK FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- CUTTING ELECTRODE MONO 26FR 0° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation, 26 Fr, loop: round, wire Ø 0.35 mm, fork color black, stem color transparent, PACK = 5 PCS, for Shark Resectoscope, sterile, for single use FDA UDI
- Model / Reference
- 46792635 FDA UDI
- Description
- CUTTING ELECTRODE MONO 26FR 0° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation, 26 Fr, loop: round, wire Ø 0.35 mm, fork color black, stem color transparent, PACK = 5 PCS, for Shark Resectoscope, sterile, for single use FDA UDI
Identifiers
- Catalog Number
- 46792635 FDA UDI
- Primary DI / UDI-DI
- 04055207053669 FDA UDI
- FDA Product Code
- FAS FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 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
No
FDA UDI
Dimensions & Sizes
- Size
- Angle — 0 degree FDA UDIOuter Diameter — 8.66666666666 Millimeter FDA UDI
Category: Endoscopic electrosurgical electrode, monopolar, single-use
Shark by Richard Wolf GmbH — 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
- Richard Wolf GmbH
Sources (1)
- FDA UDI 4de120ec-d9ac-449e-bc6b-777587f70bd4 37 fields · synced Jun 8, 2026