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Inion CPS/OTPS instrumentation
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref INS-9054 Model INS-9054 Ref INS-9054
by Inion Oy
Identity
- Trade Name
- Inion CPS/OTPS instrumentation EUDAMEDInion CPS™/OTPS™ instrumentation FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Inion CPS/OTPS instrumentation EUDAMEDInion Instruments EUDAMED1.2 mm drill bit with 16 mm stop (J-latch) FDA UDI
- Model / Reference
- INS-9054 EUDAMED1 FDA UDI
- Description
- 1.2 mm drill bit with 16 mm stop (J-latch) FDA UDI
Identifiers
- Catalog Number
- INS-9054 FDA UDI
- Primary DI / UDI-DI
- 06438408001413 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408001413 EUDAMED6438408INION-IIA-INSTRUUR EUDAMED
- Secondary DI
- M224INS905410 EUDAMED
- Direct Marketing DI
- 06438408001413 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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 CPS/OTPS instrumentation by Inion Oy — Class IIa — 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-06438408001413 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06438408001413 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (4)
- EUDAMED e307e30a-8fea-44f3-8b11-33c6615f35e1 61 fields · synced Aug 4, 2026
- EUDAMED e9165683-14ef-463e-8bdf-25a1c45d1e55 61 fields · synced May 16, 2026
- FDA UDI 3d7690aa-4f09-4c86-bd77-f9d640f6041b 34 fields · synced May 29, 2026
- EUDAMED 247a8639-3de6-4886-a389-40e2f435b199 61 fields · synced Jun 19, 2026