V. Mueller

FDA UDI

Class II (US FDA UDI)

by Steris Corporation

Identity

Trade Name: V. Mueller FDA UDI
Generic Name: Urethrotome FDA UDI
Device Name: OTIS URETHROTOME STRAIGHT with3 GUIDE TIPS and 2 KNIFE BLADES IN CASE OVERALL LENGTH 11-3/4 inches30CM FDA UDI
Model / Reference: GU4140 FDA UDI
Description: OTIS URETHROTOME STRAIGHT with3 GUIDE TIPS and 2 KNIFE BLADES IN CASE OVERALL LENGTH 11-3/4 inches30CM FDA UDI

Identifiers

Catalog Number: GU4140 FDA UDI
Primary DI / UDI-DI: 10885403050046 FDA UDI
FDA Product Code: EZO FDA UDI
GMDN Term: Urethrotome FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4770 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Urethrotome

V. Mueller by Steris Corporation — 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: Steris Corporation

Sources (1)

FDA UDI ee8017d2-4a35-413b-9e38-8d8c17583ef2 35 fields · synced Jun 8, 2026