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Inion FreedomScrew™ instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref IFS-9032
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 FreedomScrew instrument EUDAMEDInion Instruments EUDAMEDCountersink for 3.5 - 4.5 mm screws, cannulated FDA UDI
- Model / Reference
- IFS-9032 EUDAMED1 FDA UDI
- Description
- Countersink for 3.5 - 4.5 mm screws, cannulated FDA UDI
Identifiers
- Catalog Number
- IFS-9032 FDA UDI
- Primary DI / UDI-DI
- 06438408004025 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408004025 EUDAMED6438408INION-IR-INSTRUM9T EUDAMED
- Secondary DI
- M224IFS90329 EUDAMED
- Direct Marketing DI
- 06438408004025 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 — 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-06438408004025 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438408004025 | 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 d9f83ae5-efe8-48a5-bf75-0ecd1e925b17 61 fields · synced Jun 19, 2026
- EUDAMED 7e98c1ba-95a4-434a-b9c0-10401d318432 61 fields · synced May 19, 2026
- FDA UDI 87b7da2c-217c-4b8a-bfca-64b4d0736608 34 fields · synced May 30, 2026
- EUDAMED b1bdd4f4-79c4-41ce-9e11-133065ea12fb 61 fields · synced Jun 18, 2026