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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 22FR 12/30° FDA UDI
Model / Reference
46221333US FDA UDI
Description
CUTTING ELECTRODE BIPO 22FR 12/30° FDA UDI

Identifiers

Catalog Number
46221333US FDA UDI
Primary DI / UDI-DI
04055207066041 FDA UDI
FDA Product Code
HIH FDA UDI
FAS FDA UDI
GMDN Term
Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1690 FDA UDI
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 — 7.33333333333 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

Similar devices

Also classified as Endoscopic electrosurgical electrode, bipolar, single-use.

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 b157e1c8-f02d-4b08-91da-5938397df15a 37 fields · synced May 30, 2026