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E-Line

FDA UDI

Class II (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name
E-LINE FDA UDI
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Device Name
CUTTING ELECTRODE MONO 28FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent irrigation, 28, Fr, loop: round, wire Ø 0.4mm, fork color yellow, stem color blue, PACK=1 PC, for E-Line resectoscope, unsterile, reusable FDA UDI
Model / Reference
8428142 FDA UDI
Description
CUTTING ELECTRODE MONO 28FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent irrigation, 28, Fr, loop: round, wire Ø 0.4mm, fork color yellow, stem color blue, PACK=1 PC, for E-Line resectoscope, unsterile, reusable FDA UDI

Identifiers

Catalog Number
8428.142 FDA UDI
Primary DI / UDI-DI
04055207017364 FDA UDI
FDA Product Code
FAS FDA UDI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4300 FDA UDI
Commercial Distribution
Not 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

E-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 08f44009-e9c4-48b9-b498-51161453fc50 37 fields · synced May 30, 2026