← Back to catalogue
Inion OTPS™ Pin instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9242
by Inion Oy
Identity
- Trade Name
- Inion OTPS™ Pin instruments EUDAMEDInion OTPS Pin Instruments EUDAMEDFDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- Inion OTPS Pin instrument EUDAMEDInion Instruments EUDAMEDPercutaneous tip 2.0 mm FDA UDI
- Model / Reference
- INS-9242 EUDAMED1 FDA UDI
- Description
- Percutaneous tip 2.0 mm FDA UDI
Identifiers
- Catalog Number
- INS-9242 FDA UDI
- Primary DI / UDI-DI
- 06438408004728 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408004728 EUDAMED6438408INION-IR-INSTRUM9T EUDAMED
- Direct Marketing DI
- 06438408004728 EUDAMED
- FDA Product Code
- LXH 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
- 888.4540 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 — 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-06438408004728 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438408004728 | 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 (4)
- EUDAMED 7f8ff60b-10bd-4ab3-bd5c-d06cf91ab3f6 61 fields · synced Jul 21, 2026
- EUDAMED 275193fb-d47f-42d0-98bb-f3b9986530e6 61 fields · synced May 17, 2026
- FDA UDI 60d8cfc8-b813-4740-a691-e9c306a4f81b 34 fields · synced May 29, 2026
- EUDAMED 8f3c7bcc-c7dc-42f5-b6e2-24ea4e582a95 61 fields · synced Jun 18, 2026