Identity
- Trade Name
- Dilation set FDA UDI
- Generic Name
- Urethral bougie, reusable FDA UDI
- Model / Reference
- 195 800 050BC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059082009667 FDA UDI
- 510(k) Number
- K945266 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Urethral bougie, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
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
Cleared under the same submission
K945266 also covers:
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Biopsy forceps — SOPRO-COMEG GmbH
- Biopsy forceps — SOPRO-COMEG GmbH
- Biopsy forceps — SOPRO-COMEG GmbH
- Biopsy forceps — SOPRO-COMEG GmbH
- Dilation set — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
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 9ae99581-08b5-42f6-8c1d-6c84682a0a38 33 fields · synced May 30, 2026