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Inion FreedomScrew Instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref IFS-9042
by Inion Oy
Identity
- Trade Name
- Inion FreedomScrew Instrumentation EUDAMEDInion FreedomScrew™ instrumentation EUDAMEDInion FreedomScrew instruments FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion FreedomScrew instrument EUDAMEDDepth gauge for Ø2.7 - 4.5 mm screws, with K-wire (INS-9092) FDA UDI
- Model / Reference
- IFS-9042 EUDAMED1 FDA UDI
- Description
- Depth gauge for Ø2.7 - 4.5 mm screws, with K-wire (INS-9092) FDA UDI
Identifiers
- Catalog Number
- IFS-9042 FDA UDI
- Primary DI / UDI-DI
- 06438408004049 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IRM-INSTRUAF EUDAMEDB-06438408004049 EUDAMED
- Secondary DI
- M224IFS90429 EUDAMED
- Direct Marketing DI
- 06438408004049 EUDAMED
- FDA Product Code
- HTJ FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4300 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
Yes
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 FreedomScrew Instrumentation by Inion Oy — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438408INION-IRM-INSTRUAF | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438408INION-IRM-INSTRUAF | 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 (4)
- EUDAMED cda628f3-8f70-4954-98e4-a65a0669c825 61 fields · synced Aug 2, 2026
- EUDAMED 45c1ff36-d21e-4ee1-bb3f-e70d3bd22c23 61 fields · synced May 19, 2026
- FDA UDI 04f29de5-a91d-4698-be44-94880c71a6b7 34 fields · synced May 30, 2026
- EUDAMED 47ff158d-d756-4856-988b-88b432df6023 61 fields · synced Jun 19, 2026