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Opening Reamer Ø13.0mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref INS‐1106
by OrthoXel DAC
Identity
- Trade Name
- Opening Reamer Ø13.0mm EUDAMEDApex FDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- Opening Reamer Ø13.0mm EUDAMEDFDA UDI
- Model / Reference
- INS‐1106 EUDAMEDINS-1106 FDA UDI
- Description
- Opening Reamer Ø13.0mm FDA UDI
Identifiers
- Catalog Number
- INS-1106 FDA UDI
- Primary DI / UDI-DI
- 05391529582746 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529582746 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Cannulated surgical drill bit, reusable 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
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
Opening Reamer Ø13.0mm by OrthoXel DAC — Class IIa — 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-05391529582746 | 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 4fc6bb14-8c27-48db-963f-3ec79d9058be 61 fields · synced Jul 13, 2026
- FDA UDI 04ad810e-d5e4-43ec-98b8-31949de72186 37 fields · synced May 30, 2026