Ø2.5x900mm Guidewire with Ball Tip
EUDAMEDFDA UDIClass IIa (EU MDR)
by OrthoXel DAC
Identity
- Trade Name
- Ø2.5x900mm Guidewire with Ball Tip EUDAMEDApex FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- Ø2.5x900mm Guidewire with Ball Tip EUDAMED2.5x900mm Guidewire with Ball tip FDA UDI
- Model / Reference
- INS-1069S EUDAMEDFDA UDI
- Description
- 2.5x900mm Guidewire with Ball tip FDA UDI
Identifiers
- Catalog Number
- INS-1069S FDA UDI
- Primary DI / UDI-DI
- 05391529583118 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529583118 EUDAMED
- FDA Product Code
- HXI FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Orthopaedic guidewire, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Surgical retractor/retraction system blade, single-use
Ø2.5x900mm Guidewire with Ball Tip by OrthoXel DAC — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical retractor/retraction system blade, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391529583118 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (2)
- EUDAMED 3d7c6130-de66-4696-8d3a-f29f15102776 61 fields · synced Jun 18, 2026
- FDA UDI 033a2ad4-fdc0-423b-960c-8507119e9c06 37 fields · synced May 30, 2026