Identity
- Trade Name
- 2.0 K-Wire, 85mm, Olive 35mm, 1/Pkg EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- Guide Wires (sterile, non-sterile) EUDAMED2.0 K-Wire, 85mm, Olive 35mm, 1/Pkg FDA UDI
- Model / Reference
- A-5045.66/1 EUDAMEDFDA UDI
- Description
- 2.0 K-Wire, 85mm, Olive 35mm, 1/Pkg FDA UDI
Identifiers
- Catalog Number
- A-5045.66/1 FDA UDI
- Primary DI / UDI-DI
- 07630037864691 EUDAMEDFDA UDI
- Basic UDI-DI
- 76308948014UY 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
Category: Orthopaedic bur, reusable
Aptus by Medartis Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bur, reusable.
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- Midas Rex Clearview™ — MEDTRONIC XOMED, INC. · Class II
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD · Class II
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medartis Inc.
Sources (2)
- FDA UDI 09c8d608-3066-4a51-ab96-844cdad6fda4 34 fields · synced Aug 4, 2026
- EUDAMED d9a399dc-f40e-4ef1-95a4-9c22c2da9412 61 fields · synced Aug 4, 2026