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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 16FR 0° for resectoscopes, telescope Ø 3.3mm, for sheaths, intermittent irrigation, 16, Fr, loop: round, wire Ø 0.3mm, fork color yellow, stem color yellow, PACK=1 PC, for E-Line resectoscope, unsterile, reusable FDA UDI
Model / Reference
841803 FDA UDI
Description
CUTTING ELECTRODE MONO 16FR 0° for resectoscopes, telescope Ø 3.3mm, for sheaths, intermittent irrigation, 16, Fr, loop: round, wire Ø 0.3mm, fork color yellow, stem color yellow, PACK=1 PC, for E-Line resectoscope, unsterile, reusable FDA UDI

Identifiers

Catalog Number
8418.03 FDA UDI
Primary DI / UDI-DI
04055207010112 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

Dimensions & Sizes

Size
Angle — 0 degree FDA UDI
Outer Diameter — 5.33333333333 Millimeter 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 7aa3b975-604a-490a-a37d-06026d5ba167 37 fields · synced May 31, 2026