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Long Insertion Handle
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1110
by OrthoXel DAC
Identity
- Trade Name
- Long Insertion Handle EUDAMEDApex FDA UDI
- Generic Name
- Orthopaedic implant aiming arm FDA UDI
- Device Name
- Long Insertion Handle EUDAMEDFDA UDI
- Model / Reference
- INS-1110 EUDAMEDFDA UDI
- Description
- Long Insertion Handle FDA UDI
Identifiers
- Catalog Number
- INS-1110 FDA UDI
- Primary DI / UDI-DI
- 05391529584078 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529584078 EUDAMED
- 510(k) Number
- K170972 FDA UDI
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implant aiming arm FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3020 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
No
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
Long Insertion Handle 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-05391529584078 | 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 a897e3d0-0579-4ec6-bc3d-922f151e1ce4 61 fields · synced Jun 18, 2026
- FDA UDI ad7de2a3-c8b4-40bb-b8a8-e6553446d8b2 37 fields · synced May 29, 2026