Shark

FDA UDI

Class II (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name: SHARK FDA UDI
Generic Name: Endoscope sheath, reusable FDA UDI
Device Name: OUTER SHEATH RESECTOSCOPE 24FR SL 189mm, round, rotatable, distal end straight, continuous irrigation, compatible with Shark inner sheath 8675322, and telescopes Ø 4mm, 0°/12°/30°, Snap-On lock, reusable FDA UDI
Model / Reference: 8675424 FDA UDI
Description: OUTER SHEATH RESECTOSCOPE 24FR SL 189mm, round, rotatable, distal end straight, continuous irrigation, compatible with Shark inner sheath 8675322, and telescopes Ø 4mm, 0°/12°/30°, Snap-On lock, reusable FDA UDI

Identifiers

Catalog Number: 8675424 FDA UDI
Primary DI / UDI-DI: 04055207019665 FDA UDI
FDA Product Code: FJL FDA UDI
GMDN Term: Endoscope sheath, reusable 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 8 Millimeter FDA UDI

Category: Endoscope sheath, reusable

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

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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 b3e14d77-09a1-42cc-98f4-3ccd75e9c7f1 36 fields · synced Jun 8, 2026