← Back to catalogue
Inion FreedomPin Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9288Ref INS-9285 Ref INS-9285
by Inion Oy
Identity
- Trade Name
- Inion FreedomPin Instruments EUDAMEDFDA UDIInion FreedomPin™ Instruments EUDAMED
- Generic Name
- Bone tack inserter, basic FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion FreedomPin Instruments EUDAMEDApplicator 3.2 mm FDA UDIApplicator 2.7 mm FDA UDI
- Model / Reference
- INS-9288 EUDAMEDINS-9285 EUDAMED1 FDA UDI
- Description
- Applicator 3.2 mm FDA UDIApplicator 2.7 mm FDA UDI
Identifiers
- Catalog Number
- INS-9288 FDA UDIINS-9285 FDA UDI
- Primary DI / UDI-DI
- 06438408004551 EUDAMEDFDA UDI06438408004520 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IRM-INSTRUAF EUDAMEDB-06438408004520 EUDAMEDB-06438408004551 EUDAMED
- Secondary DI
- M224INS92889 EUDAMEDM224INS92859 EUDAMED
- Direct Marketing DI
- 06438408004551 EUDAMED06438408004520 EUDAMED
- FDA Product Code
- HXJ FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Bone tack inserter, basic 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
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 FreedomPin Instruments 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (8)
- EUDAMED 81f6ce4f-4969-45f7-b808-cf3dad9d8113 61 fields · synced Jul 30, 2026
- EUDAMED 6cf43d91-3a7d-4056-b9d2-49d5b079899c 61 fields · synced May 17, 2026
- EUDAMED 629eddfe-0205-4cd2-af44-bba1a0178c86 61 fields · synced May 18, 2026
- EUDAMED 68a00329-5ca5-454c-a0b7-10e9c73e7209 61 fields · synced May 19, 2026
- FDA UDI a3f7ce2e-40bd-41fe-9120-edbbd724627a 34 fields · synced May 29, 2026
- FDA UDI 41abaea6-2dbe-45d5-9ac5-4430f793572c 34 fields · synced May 30, 2026
- EUDAMED 43fbaac2-41af-427f-96ea-1b87b251c362 61 fields · synced Jun 19, 2026
- EUDAMED 03cc6208-754c-4a6c-be44-9cd838fe78f7 61 fields · synced Jul 30, 2026