Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- Cranial drill/burr EUDAMEDMCKENZIE TWIST DRILL 13MM DIA FDA UDI
- Model / Reference
- FF066R EUDAMEDFDA UDI
- Description
- MCKENZIE TWIST DRILL 13MM DIA FDA UDI
Identifiers
- Catalog Number
- FF066R FDA UDI
- Primary DI / UDI-DI
- 04038653163007 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000028913J EUDAMED
- Direct Marketing DI
- 04038653163007 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L1104 BITS FOR NEUROSURGERY DRILLS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic bur, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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
Yes
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 | 40392390000028913J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED fe0c488a-41c5-4b93-a915-f3a0ade957bc 61 fields · synced Jul 12, 2026
- FDA UDI f7b99185-133a-407c-b058-b62c90824486 35 fields · synced May 30, 2026