Medicon

FDA UDI

Class I (US FDA UDI)

by Medicon eG. Chirurgiemechaniker-Genossenschaft

Identity

Trade Name: Medicon FDA UDI
Generic Name: Urethral bougie, reusable FDA UDI
Device Name: Dittel urethral sound 8 Fr cvd 33.5cm FDA UDI
Model / Reference: 51.61.08 FDA UDI
Description: Dittel urethral sound 8 Fr cvd 33.5cm FDA UDI

Identifiers

Catalog Number: 51.61.08 FDA UDI
Primary DI / UDI-DI: 04046826060954 FDA UDI
FDA Product Code: FBX FDA UDI
GMDN Term: Urethral bougie, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5520 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

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Urethral bougie, reusable

Dittel Urethral Sound 8 Fr cvd 33.5cm is a medical device designed to explore the urethra and/or dilate a urinary meatus stenosis with a semi-rigid tapered shaft that terminates in a small bulbous tip (an olive). This instrument is typically hollow for passage of other slender devices, making it a reusable device.

Similar devices

Also classified as Urethral bougie, reusable.

Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Dilation set — SOPRO-COMEG GmbH · Class II
Ambler Surgical — Ambler Surgical, LLC · Class I
American Medicals — AMERICAN MEDICALS · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Accessory for urology — 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: Medicon eG. Chirurgiemechaniker-Genossenschaft

Sources (1)

FDA UDI 90f85487-bc6e-45e0-ac1c-8fdb897fb544 35 fields · synced Jun 29, 2026