Identity
- Trade Name
- SHARK FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- COAG ELECTRODE MONO 26FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation, 26 Fr, electrode shape: button, fork color black, stem color transparent, PACK = 5 PCS, for Shark Resectoscope, sterile, for single use FDA UDI
- Model / Reference
- 46782603 FDA UDI
- Description
- COAG ELECTRODE MONO 26FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation, 26 Fr, electrode shape: button, fork color black, stem color transparent, PACK = 5 PCS, for Shark Resectoscope, sterile, for single use FDA UDI
Identifiers
- Catalog Number
- 46782603 FDA UDI
- Primary DI / UDI-DI
- 04055207053508 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
- Outer 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 5041b8d4-5702-42c5-94ee-14040cea9176 37 fields · synced May 30, 2026