RZ Medizintechnik GmbH

FDA UDI

Class I (US FDA UDI)

by RZ-Medizintechnik GmbH

Identity

Trade Name: RZ Medizintechnik GmbH FDA UDI
Generic Name: Urethrotome FDA UDI
Device Name: OTIS Urethrotome complete 2 knifes, 3 autraumatic tips in wooden case FDA UDI
Model / Reference: 253-500-100 FDA UDI
Description: OTIS Urethrotome complete 2 knifes, 3 autraumatic tips in wooden case FDA UDI

Identifiers

Catalog Number: 253-500-100 FDA UDI
Primary DI / UDI-DI: 04049197183840 FDA UDI
FDA Product Code: FCL FDA UDI
GMDN Term: Urethrotome FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.1075 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

RZ Medizintechnik GmbH by RZ-Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Urethrotomy knife — SOPRO-COMEG GmbH · 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 I	Pending data

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Manufacturer

Manufacturer: RZ-Medizintechnik GmbH

Sources (1)

FDA UDI 1e901201-4deb-477c-903a-bc04d0bde7d2 35 fields · synced Jun 1, 2026