Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Urethral dilator, reusable FDA UDI
- Device Name
- Dittel and Guyon dilator EUDAMEDDITTEL Urethral Bougie, curved, 13 1/2", (345 mm), diam. Charr. 18, stiff, non-sterile, reusable FDA UDI
- Model / Reference
- EF648R EUDAMEDFDA UDI
- Description
- DITTEL Urethral Bougie, curved, 13 1/2", (345 mm), diam. Charr. 18, stiff, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- EF648R FDA UDI
- Primary DI / UDI-DI
- 04038653039487 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000004372A EUDAMED
- Direct Marketing DI
- 04038653039487 EUDAMED
- FDA Product Code
- FAX FDA UDI
- EMDN Code
- L06050101 NON-ENDOSCOPIC URETHRAL EXPANSION INSTRUMENTS, REUSABLE EUDAMED
- GMDN Term
- Urethral dilator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5520 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Aesculap by Aesculap AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40392390000004372A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 04178f5c-acd9-4e98-b602-04bf9eb51782 61 fields · synced May 30, 2026
- FDA UDI 430a5ee0-d348-4619-a958-b2bcfef6bc6e 35 fields · synced May 30, 2026