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K-Wire Ø3.2mm X Length 250mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1068
by OrthoXel DAC
Identity
- Trade Name
- K-Wire Ø3.2mm X Length 250mm EUDAMEDApex FDA UDI
- Generic Name
- Orthopaedic guidewire, reusable FDA UDI
- Device Name
- K-Wire Ø3.2mm X Length 250mm EUDAMEDFDA UDI
- Model / Reference
- INS-1068 EUDAMEDFDA UDI
- Description
- K-Wire Ø3.2mm X Length 250mm FDA UDI
Identifiers
- Catalog Number
- INS-1068 FDA UDI
- Primary DI / UDI-DI
- 05391529582791 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529582791 EUDAMED
- FDA Product Code
- HXI FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic guidewire, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
K-Wire Ø3.2mm X Length 250mm by OrthoXel DAC — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391529582791 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (2)
- EUDAMED 923ba5f6-14b7-47db-b2f6-d5d16893370d 61 fields · synced Jul 29, 2026
- FDA UDI 6097fca8-6bdb-4257-afc8-f2c8c8af094a 37 fields · synced May 30, 2026