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Inion OTPS Pin Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9231Ref INS-9230
by Inion Oy
Identity
- Trade Name
- Inion OTPS Pin Instruments EUDAMEDFDA UDIInion OTPS™ Pin instruments EUDAMED
- Generic Name
- Bone tack inserter, basic FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion OTPS Pin instrument EUDAMEDPin applicator 1.5 mm FDA UDIPin applicator 2.0 mm FDA UDI
- Model / Reference
- INS-9231 EUDAMEDINS-9230 EUDAMED1 FDA UDI
- Description
- Pin applicator 1.5 mm FDA UDIPin applicator 2.0 mm FDA UDI
Identifiers
- Catalog Number
- INS-9230 FDA UDIINS-9231 FDA UDI
- Primary DI / UDI-DI
- 06438408004704 EUDAMEDFDA UDI06438408004698 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IR-INSTRUM9T EUDAMEDB-06438408004698 EUDAMEDB-06438408004704 EUDAMED
- Secondary DI
- M224INS92319 EUDAMEDM224INS92309 EUDAMED
- Direct Marketing DI
- 06438408004704 EUDAMED06438408004698 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
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 (8)
- EUDAMED 0d364729-e79d-48d4-83d1-e0e3f2ffc4d2 61 fields · synced Jul 26, 2026
- EUDAMED c6b5ffd4-38a0-4c46-a0aa-bb574e7d1702 61 fields · synced May 16, 2026
- EUDAMED 09bdeb8f-f1ad-4f6a-8727-a2a2796117d1 61 fields · synced May 19, 2026
- EUDAMED ef361db8-712e-4c90-803a-c241f426eab5 61 fields · synced May 19, 2026
- FDA UDI a90abefd-3257-4f01-8277-8052bf6d52f9 34 fields · synced May 30, 2026
- FDA UDI 740e670c-9079-41c1-9cf5-484c04d2b694 34 fields · synced May 30, 2026
- EUDAMED 676054ef-ea7e-47a1-ad08-9e2a7bbc7dbc 61 fields · synced Jul 9, 2026
- EUDAMED 4f03e33a-db7b-4212-81de-4d161e0d45bf 61 fields · synced Jul 24, 2026