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Inion FreedomScrew instrumentation
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IFS-4004
by Inion Oy
Identity
- Trade Name
- Inion FreedomScrew instrumentation EUDAMEDInion FreedomScrew instruments FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- Inion FreedomScrew instrumentation EUDAMEDInion Instruments EUDAMEDTap Ø4.0 mm, cannulated FDA UDI
- Model / Reference
- IFS-4004 EUDAMED1 FDA UDI
- Description
- Tap Ø4.0 mm, cannulated FDA UDI
Identifiers
- Catalog Number
- IFS-4004 FDA UDI
- Primary DI / UDI-DI
- 06438408003882 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408003882 EUDAMED6438408INION-IIA-INSTRUUR EUDAMED
- Secondary DI
- M224IFS40049 EUDAMED
- FDA Product Code
- HWX FDA UDI
- EMDN Code
- L098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMED
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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 IIa — 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-06438408003882 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06438408003882 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (3)
- EUDAMED ee20bb5b-cab7-41a9-b1f5-7b9dede9d329 61 fields · synced Sep 18, 2026
- EUDAMED f3d88c06-cbe4-4bcd-a15d-fdd2529ab1d2 61 fields · synced May 18, 2026
- FDA UDI 5243664b-a8c9-452c-9da5-6d8e1b7f0d68 34 fields · synced May 30, 2026