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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
Rigid optical ureterorenoscope FDA UDI
Device Name
URETERORENOSCOPE 5° 6.5/8.5FR WL 430MM semi-rigid, with lateral ocular lens, working channel 1: 4,2FR, working channel 2: 2.4FR, atraumatic distal tip, TL 563mm, fiber image carrier FDA UDI
Model / Reference
8708534 FDA UDI
Description
URETERORENOSCOPE 5° 6.5/8.5FR WL 430MM semi-rigid, with lateral ocular lens, working channel 1: 4,2FR, working channel 2: 2.4FR, atraumatic distal tip, TL 563mm, fiber image carrier FDA UDI

Identifiers

Catalog Number
8708.534 FDA UDI
Primary DI / UDI-DI
04055207020173 FDA UDI
FDA Product Code
FGB FDA UDI
GMDN Term
Rigid optical ureterorenoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 430 Millimeter FDA UDI
Angle — 5 degree FDA UDI

Category: Rigid optical ureterorenoscope

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

Similar devices

Also classified as Rigid optical ureterorenoscope.

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 0ce242f4-f3f4-446f-82b4-5cab987aae81 36 fields · synced May 30, 2026