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Inion Hexalon™ Instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9203
by Inion Oy
Identity
- Trade Name
- Inion Hexalon™ Instrumentation EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Inion Hexalon Instrument EUDAMEDGuide wire 38 cm FDA UDI
- Model / Reference
- INS-9203 EUDAMED1 FDA UDI
- Description
- Guide wire 38 cm FDA UDI
Identifiers
- Catalog Number
- INS-9203 FDA UDI
- Primary DI / UDI-DI
- 06438408002564 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408002564 EUDAMED6438408HEXALONINSTIR54 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Finland 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Inion Hexalon™ Instrumentation by Inion Oy — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438408002564 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438408002564 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (3)
- EUDAMED ea74758d-9652-4fbb-8bdb-b80e60f70fc3 61 fields · synced Jul 29, 2026
- EUDAMED 87e230dc-ac75-435f-a324-0bc0e17dfa90 61 fields · synced May 19, 2026
- FDA UDI 57cef7d1-a3d2-403e-be58-428039f92824 34 fields · synced May 30, 2026