Cobra

FDA UDI

Class II (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name: COBRA FDA UDI
Generic Name: Flexible fibreoptic ureterorenoscope FDA UDI
Device Name: FIBER-URETERORENOSCOPE 9.9FR WL 680MM flexible, working channel 1: 3.3Fr, working channel 1: 3.3Fr, slanted distal tip Ø 6 Fr, TL 1010mm, deflection +270°/-270°, laser shifter for laser fiber fixation and guidance, locking lever for the distal tip, glass fiber light cable, fiber image carrier, manual focus FDA UDI
Model / Reference: 7326071 FDA UDI
Description: FIBER-URETERORENOSCOPE 9.9FR WL 680MM flexible, working channel 1: 3.3Fr, working channel 1: 3.3Fr, slanted distal tip Ø 6 Fr, TL 1010mm, deflection +270°/-270°, laser shifter for laser fiber fixation and guidance, locking lever for the distal tip, glass fiber light cable, fiber image carrier, manual focus FDA UDI

Identifiers

Catalog Number: 7326071 FDA UDI
Primary DI / UDI-DI: 04055207013748 FDA UDI
FDA Product Code: FAJ FDA UDI
GMDN Term: Flexible fibreoptic 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Hydrogen Peroxide FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.3 Millimeter FDA UDI
Length — 680 Millimeter FDA UDI

Category: Flexible fibreoptic ureterorenoscope

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

Similar devices

Also classified as Flexible fibreoptic ureterorenoscope.

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Flex-X — Karl Storz GmbH & Co. KG · Class II
URETERO-RENO FIBERSCOPE — Olympus Medical Systems Corporation · Class II
URETERO-RENO FIBERSCOPE — Olympus Medical Systems Corporation · Class II
FIBER URETEROSCOPE — PENTAX of America, Inc. · Class II
URETERO-RENO FIBERSCOPE — Olympus Medical Systems Corporation · Class II
URETERO-RENO FIBERSCOPE — Olympus Medical Systems Corporation · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Richard Wolf GmbH

Sources (1)

FDA UDI c57935cf-19f0-4127-9615-c443f083c520 36 fields · synced Jun 8, 2026