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Inion Shoulder Instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9613
by Inion Oy
Identity
- Trade Name
- Inion Shoulder Instrumentation EUDAMEDInion® Shoulder Instrumentation FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- Inion Shoulder Instrument EUDAMEDGlenoid rasp FDA UDI
- Model / Reference
- INS-9613 EUDAMED1 FDA UDI
- Description
- Glenoid rasp FDA UDI
Identifiers
- Catalog Number
- INS-9613 FDA UDI
- Primary DI / UDI-DI
- 06438408007200 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408007200 EUDAMED
- FDA Product Code
- HTR FDA UDI
- EMDN Code
- L091201 ORTHOPAEDIC SURGERY RASPS, REUSABLE EUDAMED
- GMDN Term
- Bone file/rasp, manual, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- Not 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 Shoulder Instrumentation by Inion Oy — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438408007200 | 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 (2)
- EUDAMED e9f70ec0-5266-45b5-bb19-0c21bdf9451d 61 fields · synced Aug 1, 2026
- FDA UDI ac1a844c-3b1a-46f0-a241-a7de0963410e 35 fields · synced May 30, 2026