Identity
- Trade Name
- SHARK FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- COAG ELECTRODE MONO 22-24FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 22/24/26 Fr, electrode shape: button, fork color green, stem color transparent, PACK = 5 PCS, for Shark Resectoscope, sterile, for single use FDA UDI
- Model / Reference
- 46782203 FDA UDI
- Description
- COAG ELECTRODE MONO 22-24FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 22/24/26 Fr, electrode shape: button, fork color green, stem color transparent, PACK = 5 PCS, for Shark Resectoscope, sterile, for single use FDA UDI
Identifiers
- Catalog Number
- 46782203 FDA UDI
- Primary DI / UDI-DI
- 04055207053447 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Endoscopic electrosurgical electrode, monopolar, single-use
Introducing the SHARK COAG ELECTRODE MONO, a reliable and versatile electrosurgical electrode designed for use in resectoscopes, telescopes, sheaths, and other medical instruments. This single-use device is available in various forms and features an ergonomic design, making it easy to maneuver during procedures. With its monopolar configuration and button-shaped electrode tip, the SHARK COAG ELECTRODE MONO ensures effective coagulation and cutting of tissues. The device is designed for use in a variety of medical specialties, including gastroenterology and urology.
Similar devices
Also classified as Endoscopic electrosurgical electrode, monopolar, single-use.
- Bowel Grasper Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- FlexTrode® Malleable Electrode — ELLIQUENCE LLC · Class II
- BOVIE — BOVIE MEDICAL CORPORATION · Class II
- USA Elite — Gyrus Acmi, Inc. · Class II
- Dorsey Grasper Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- 5mm x 10mm Foam Sleeves — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- CleanCoat — Covidien LP · Class II
- Stainless Steel Cardiac 2 Finger Heart Retractor - Large — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Richard Wolf GmbH
Sources (1)
- FDA UDI ad63c4fa-1b65-4552-b057-9d4e8c672d0d 36 fields · synced Jul 7, 2026