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Shark/S-Line

FDA UDI

Class II (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name
SHARK/S-LINE FDA UDI
Generic Name
Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
Device Name
CUTTING ELECTRODE BIPO 26FR 0° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent irrigation, 26, Fr, loop: round, wire Ø 0.3mm, fork color green, stem color blue, PACK=3 PCS, for Shark and S-Line Resectoscopes, sterile, for single use FDA UDI
Model / Reference
46110313 FDA UDI
Description
CUTTING ELECTRODE BIPO 26FR 0° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent irrigation, 26, Fr, loop: round, wire Ø 0.3mm, fork color green, stem color blue, PACK=3 PCS, for Shark and S-Line Resectoscopes, sterile, for single use FDA UDI

Identifiers

Catalog Number
4611.0313 FDA UDI
Primary DI / UDI-DI
04055207048849 FDA UDI
FDA Product Code
JOS FDA UDI
GMDN Term
Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
Not 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

Shark/S-Line by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Richard Wolf GmbH

Sources (1)

  • FDA UDI 2a961c7b-ed50-4a0f-a05e-447870e036d5 37 fields · synced Jun 8, 2026