Identity
- Trade Name
- SHARK FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- HOOK ELECTRODE BIPO 22-26FR 12/30° for resectoscope, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation 22/24/26Fr, electrode shape: hook, PACK=1 PC, for Shark Resectoscopes, branch color: blue, stem color: yellow, unsterile, reusable FDA UDI
- Model / Reference
- 862309 FDA UDI
- Description
- HOOK ELECTRODE BIPO 22-26FR 12/30° for resectoscope, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation 22/24/26Fr, electrode shape: hook, PACK=1 PC, for Shark Resectoscopes, branch color: blue, stem color: yellow, unsterile, reusable FDA UDI
Identifiers
- Catalog Number
- 862309 FDA UDI
- Primary DI / UDI-DI
- 04055207010792 FDA UDI
- FDA Product Code
- FAS FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, reusable 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
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
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Shark by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, reusable.
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- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- V. Mueller — STERIS CORPORATION · Class II
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 8ee20eaf-fbb3-4d83-9ac7-65440e1d0a1b 35 fields · synced May 30, 2026