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5.0 CCS Twist Drill Ø3.1mm, L177mm, AO
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A-8000.03SRef A-8000.03
by Medartis AG
Identity
- Trade Name
- 5.0 CCS Twist Drill Ø3.1mm, L177mm, AO EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- Rotating and cutting instruments (connected to an active device) EUDAMED5.0 CCS Twist Drill Ø3.1mm, L177mm, AO FDA UDI
- Model / Reference
- A-8000.03S EUDAMEDA-8000.03 EUDAMEDFDA UDI
- Description
- 5.0 CCS Twist Drill Ø3.1mm, L177mm, AO FDA UDI
Identifiers
- Catalog Number
- A-8000.03 FDA UDI
- Primary DI / UDI-DI
- 07630037866039 EUDAMED07630037866022 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378015PD EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
- GMDN Term
- Orthopaedic bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMEDFDA 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
5.0 CCS Twist Drill Ø3.1mm, L177mm, AO by Medartis AG — Class IIa — 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 | 76300378015PD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medartis AG
- EUDAMED SRN
- CH-MF-000022291
- Authorised Representative
- Medartis GmbH DE-AR-000005810
Sources (3)
- EUDAMED c71efc9a-b5d2-4b99-988f-c62446f8d605 61 fields · synced Jul 10, 2026
- EUDAMED 910fed1c-9a59-4ee8-a901-b7eb6ecf4a63 61 fields · synced May 19, 2026
- FDA UDI 074261ff-1ff1-4517-953e-d7bcc0183da1 34 fields · synced May 30, 2026