Princess

FDA UDI

Class II (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name: PRINCESS FDA UDI
Generic Name: Endoscope sheath, reusable FDA UDI
Device Name: OUTER SHEATH RESECTOSCOPE 21FR color code black, SL 199mm, round, compatible with inner sheath 8653018 for Princess resectoscope 21Fr with continuous irrigation, and telescopes Ø 2.7mm, 12°, with Luer connection, E-Line quick connection, reusable FDA UDI
Model / Reference: 8653021 FDA UDI
Description: OUTER SHEATH RESECTOSCOPE 21FR color code black, SL 199mm, round, compatible with inner sheath 8653018 for Princess resectoscope 21Fr with continuous irrigation, and telescopes Ø 2.7mm, 12°, with Luer connection, E-Line quick connection, reusable FDA UDI

Identifiers

Catalog Number: 8653.021 FDA UDI
Primary DI / UDI-DI: 04055207042878 FDA UDI
FDA Product Code: FDC 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 — 7 Millimeter FDA UDI

Category: Endoscope sheath, reusable

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

Similar devices

Also classified as Endoscope sheath, reusable.

Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
B.I.O.H. — Karl Storz GmbH & Co. KG · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class I
SpineTIP — Karl Storz GmbH & Co. KG · Class II
Surgical Direct — SURGICAL DIRECT, INC. · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Richard Wolf GmbH

Sources (1)

FDA UDI 6f64c718-e4bf-43f4-a5a8-a02dcdf96453 36 fields · synced Jun 1, 2026