Identity
- Trade Name
- Medicon FDA UDI
- Generic Name
- Urethral bougie, reusable FDA UDI
- Device Name
- Guyon urethral sound 25 Fr 26cm FDA UDI
- Model / Reference
- 51.67.25 FDA UDI
- Description
- Guyon urethral sound 25 Fr 26cm FDA UDI
Identifiers
- Catalog Number
- 51.67.25 FDA UDI
- Primary DI / UDI-DI
- 04046826062323 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Urethral bougie, reusable
Medicon by Medicon eG. Chirurgiemechaniker-Genossenschaft — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urethral bougie, reusable.
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- 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 8b0abfbe-5a1f-4b79-9e5f-20f5067f9a1d 35 fields · synced May 30, 2026