Identity
- Trade Name
- 1.6 K-Wire, 70mm, Olive 20mm, No Thread EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Device Name
- Guide Wires (sterile, non-sterile) EUDAMED1.6 K-Wire, 70mm, Olive 20mm, No Thread FDA UDI
- Model / Reference
- A-5046.43/2S EUDAMEDFDA UDI
- Description
- 1.6 K-Wire, 70mm, Olive 20mm, No Thread FDA UDI
Identifiers
- Catalog Number
- A-5046.43/2S FDA UDI
- Primary DI / UDI-DI
- 07630894810893 EUDAMEDFDA UDI
- Basic UDI-DI
- 76308948014UY EUDAMED
- Unit of Use DI
- 07630894820960 EUDAMED
- FDA Product Code
- GDF FDA UDI
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
- GMDN Term
- Orthopaedic intraoperative positioning pin, 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
No
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 intraoperative positioning pin, single-use
Aptus by Medartis Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic intraoperative positioning pin, single-use.
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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 00c5e7f4-ff63-4cd6-98c8-e6e7086ec260 34 fields · synced Jun 18, 2026
- EUDAMED d28ea7be-7316-4a46-82e0-5391c384e0a8 61 fields · synced Jun 18, 2026