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Inion OTPS Pin / FreedomPin instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9240
by Inion Oy
Identity
- Trade Name
- Inion OTPS Pin / FreedomPin instrumentation EUDAMEDInion FreedomPin Instruments FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- Inion Instruments EUDAMEDWrench FDA UDI
- Model / Reference
- INS-9240 EUDAMED1 FDA UDI
- Description
- Wrench FDA UDI
Identifiers
- Catalog Number
- INS-9240 FDA UDI
- Primary DI / UDI-DI
- 06438408004575 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INIONCLASS1ZE EUDAMED
- FDA Product Code
- HXC FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical torque wrench, 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 OTPS Pin / FreedomPin instrumentation by Inion Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438408INIONCLASS1ZE | 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 (2)
- EUDAMED d3b0d933-9580-4546-8af1-603d1b22408e 61 fields · synced Jun 19, 2026
- FDA UDI cd88293a-aba4-4c1a-b2d6-f442cf489a53 34 fields · synced May 30, 2026