Identity
- Trade Name
- 2.0 K-Wire, 60mm, Olive 10mm EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- Guide Wires (sterile, non-sterile) EUDAMED2.0 K-Wire, 60mm, Olive 10mm FDA UDI
- Model / Reference
- A-5045.61/2S EUDAMEDFDA UDI
- Description
- 2.0 K-Wire, 60mm, Olive 10mm FDA UDI
Identifiers
- Catalog Number
- A-5045.61/2S FDA UDI
- Primary DI / UDI-DI
- 07630037864608 EUDAMEDFDA UDI
- Basic UDI-DI
- 76308948014UY EUDAMED
- Unit of Use DI
- 07630894820533 EUDAMED
- FDA Product Code
- GDF FDA UDI
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
- GMDN Term
- Orthopaedic bur, single-use 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bur, single-use
Aptus by Medartis Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medartis Inc.
Sources (2)
- FDA UDI 964d1a2e-6cef-4a25-8c1a-0915ff129e2d 34 fields · synced Jun 18, 2026
- EUDAMED fdd726a5-077f-4aed-b622-9d62566cbe1b 61 fields · synced Jun 18, 2026