← Back to catalogue
Inion FreedomScrew Instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref IFS-9031
by Inion Oy
Identity
- Trade Name
- Inion FreedomScrew Instrumentation EUDAMEDInion FreedomScrew™ instrumentation EUDAMEDInion FreedomScrew instruments FDA UDI
- Generic Name
- Surgical countersink, reusable FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion FreedomScrew instrument EUDAMEDCountersink for Ø2.0/2.7 mm screws FDA UDI
- Model / Reference
- IFS-9031 EUDAMED1 FDA UDI
- Description
- Countersink for Ø2.0/2.7 mm screws FDA UDI
Identifiers
- Catalog Number
- IFS-9031 FDA UDI
- Primary DI / UDI-DI
- 06438408004018 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IR-INSTRUM9T EUDAMEDB-06438408004018 EUDAMED
- Secondary DI
- M224IFS90319 EUDAMED
- Direct Marketing DI
- 06438408004018 EUDAMED
- FDA Product Code
- HWW FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical countersink, 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 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-IR-INSTRUM9T | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438408INION-IR-INSTRUM9T | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (4)
- EUDAMED 78886efa-6440-4f4e-9949-cc05e9aa3d1f 61 fields · synced Jun 18, 2026
- EUDAMED 788a3df2-922d-4963-b8c8-8ef8056aadd7 61 fields · synced May 19, 2026
- FDA UDI f3ed44f7-5b3a-45e6-adcc-dba71442e512 34 fields · synced May 24, 2026
- EUDAMED 05a9fe66-aabc-4e74-ab93-1bdaf4745c38 61 fields · synced Jun 18, 2026