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1.6 K-Wire, 65mm, Olive 15mm, 1/Pkg
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A-5045.42/1
by Medartis AG
Identity
- Trade Name
- 1.6 K-Wire, 65mm, Olive 15mm, 1/Pkg EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- Rotating and cutting instruments (connected to an active device) EUDAMED1.6 K-Wire, 65mm, Olive 15mm, 1/Pkg FDA UDI
- Model / Reference
- A-5045.42/1 EUDAMEDFDA UDI
- Description
- 1.6 K-Wire, 65mm, Olive 15mm, 1/Pkg FDA UDI
Identifiers
- Catalog Number
- A-5045.42/1 FDA UDI
- Primary DI / UDI-DI
- 07630037864479 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378015PD EUDAMED
- FDA Product Code
- GDF 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
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
1.6 K-Wire, 65mm, Olive 15mm, 1/Pkg 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 (2)
- EUDAMED d2bcd2b5-ffb8-4094-bae1-1d62d96a217d 61 fields · synced Oct 6, 2026
- FDA UDI 5aee3888-2ce5-475e-8b80-2ebf3637f7fe 34 fields · synced May 29, 2026