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Inion CompressOn screw Instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref IFS-9044
by Inion Oy
Identity
- Trade Name
- Inion CompressOn screw Instrumentation EUDAMEDInion CompressOn™ Instrument FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion CompressOn Screw instrumentation EUDAMEDDepth gauge for 230 mm K-wire FDA UDI
- Model / Reference
- IFS-9044 EUDAMED1 FDA UDI
- Description
- Depth gauge for 230 mm K-wire FDA UDI
Identifiers
- Catalog Number
- IFS-9044 FDA UDI
- Primary DI / UDI-DI
- 06438408008894 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IRM-INSTRUAF EUDAMEDB-06438408008894 EUDAMED
- Direct Marketing DI
- 06438408008894 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 CompressOn screw 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 d1b186ad-5d63-437a-911d-93ed35fba8e7 61 fields · synced Jul 26, 2026
- EUDAMED 284c5595-b3cf-48da-b89b-05b9df00729f 61 fields · synced May 17, 2026
- FDA UDI 44741436-8ace-4580-ad69-1b5ddd401b21 34 fields · synced May 30, 2026
- EUDAMED 05d23004-9f6f-409a-84d4-330813a2beee 61 fields · synced Jun 19, 2026