Identity
- Trade Name
- Dilation set FDA UDI
- Generic Name
- Urethral bougie, reusable FDA UDI
- Model / Reference
- 191 402 257 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059082033228 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Urethral bougie, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Urethral bougie, reusable
Dilation set by SOPRO-COMEG GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Urethral bougie, reusable.
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- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
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
- SOPRO-COMEG GmbH
Sources (1)
- FDA UDI 20774a9a-46d4-4f2c-aaa2-3a1f969daf31 32 fields · synced Jun 1, 2026