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Large AO to ZIH Adapter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref INS-1191
by OrthoXel DAC
Identity
- Trade Name
- Large AO to ZIH Adapter EUDAMEDApex FDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Device Name
- Large AO to ZIH Adapter EUDAMEDFDA UDI
- Model / Reference
- INS-1191 EUDAMEDFDA UDI
- Description
- Large AO to ZIH Adapter FDA UDI
Identifiers
- Catalog Number
- INS-1191 FDA UDI
- Primary DI / UDI-DI
- 05391543064273 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391543064273 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic instrument surgical connector 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
Large AO to ZIH Adapter 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-05391543064273 | 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 b52e10c6-e8e7-4cd9-8f1a-1be0ce2c349a 61 fields · synced Jul 20, 2026
- FDA UDI 917b06dd-8167-4e05-a8e8-39450a6cbd90 36 fields · synced May 30, 2026