Identity
- Trade Name
- SHARK/S-LINE FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
- Device Name
- CUTTING ELECTRODE BIPO 24FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 24/26, Fr, loop: round, wire Ø 0.3mm, fork color blue, stem color blue, PACK=3 PCS, for Shark and S-Line Resectoscopes, sterile, for single use FDA UDI
- Model / Reference
- 46221313 FDA UDI
- Description
- CUTTING ELECTRODE BIPO 24FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 24/26, Fr, loop: round, wire Ø 0.3mm, fork color blue, stem color blue, PACK=3 PCS, for Shark and S-Line Resectoscopes, sterile, for single use FDA UDI
Identifiers
- Catalog Number
- 4622.1313 FDA UDI
- Primary DI / UDI-DI
- 04055207048856 FDA UDI
- FDA Product Code
- FAS FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, bipolar, 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 Millimeter FDA UDI
Category: Endoscopic electrosurgical electrode, bipolar, single-use
Shark/S-Line 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 bf108e18-f85d-4631-b20c-3188daca09e2 37 fields · synced Jun 1, 2026