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Inion OTPS Pin Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9234
by Inion Oy
Identity
- Trade Name
- Inion OTPS Pin Instruments EUDAMEDFDA UDIInion OTPS™ Pin instruments EUDAMED
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion OTPS Pin instrument EUDAMEDArthroscopic tip 2.0 mm FDA UDI
- Model / Reference
- INS-9234 EUDAMED1 FDA UDI
- Description
- Arthroscopic tip 2.0 mm FDA UDI
Identifiers
- Catalog Number
- INS-9234 FDA UDI
- Primary DI / UDI-DI
- 06438408004711 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IR-INSTRUM9T EUDAMEDB-06438408004711 EUDAMED
- Secondary DI
- M224INS92349 EUDAMED
- Direct Marketing DI
- 06438408004711 EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.1100 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 OTPS Pin 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-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 |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (4)
- EUDAMED 3e9926d6-b8b2-4c89-a516-60cf3e29c8f6 61 fields · synced Jul 25, 2026
- EUDAMED f0d76572-44ef-444f-93cd-44dec52bf1f3 61 fields · synced May 18, 2026
- FDA UDI 731445fc-b303-4bc7-a938-ac36c419f8ee 34 fields · synced May 29, 2026
- EUDAMED fb45bb08-c8ef-4e2c-bac0-1f11fe473fd7 61 fields · synced Jun 19, 2026