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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 cystourethroscope FDA UDI
Device Name
CYSTOSCOPE 12° 8.0/9.8FR WL 150MM rigid, with lateral ocular lens, working channel 5Fr, atraumatic distal tip, TL 283mm, rod lens system FDA UDI
Model / Reference
8626531 FDA UDI
Description
CYSTOSCOPE 12° 8.0/9.8FR WL 150MM rigid, with lateral ocular lens, working channel 5Fr, atraumatic distal tip, TL 283mm, rod lens system FDA UDI

Identifiers

Catalog Number
8626.531 FDA UDI
Primary DI / UDI-DI
04055207018071 FDA UDI
FDA Product Code
FBO FDA UDI
GMDN Term
Rigid optical cystourethroscope 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
Angle — 12 degree FDA UDI
Length — 150 Millimeter FDA UDI

Category: Rigid optical cystourethroscope

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 cystourethroscope.

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 fbb36c71-34f5-424e-afb9-dc2a8ac8a6e1 36 fields · synced May 30, 2026