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Inion Shoulder Instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9612
by Inion Oy
Identity
- Trade Name
- Inion Shoulder Instrumentation EUDAMEDInion® Shoulder Instrumentation FDA UDI
- Generic Name
- Suture knot pusher, reusable FDA UDI
- Device Name
- Inion Shoulder Instrument EUDAMEDKnot pusher FDA UDI
- Model / Reference
- INS-9612 EUDAMED1 FDA UDI
- Description
- Knot pusher FDA UDI
Identifiers
- Catalog Number
- INS-9612 FDA UDI
- Primary DI / UDI-DI
- 06438408007194 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408007194 EUDAMED
- FDA Product Code
- HXO FDA UDI
- EMDN Code
- L0207 KNOT PUSHERS, REUSABLE EUDAMED
- GMDN Term
- Suture knot pusher, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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-06438408007194 | 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 91cf72d6-5586-482d-a0e1-6a1ef347abe4 61 fields · synced Jun 20, 2026
- FDA UDI 0ed8aa17-30df-4fa3-99db-06db0098e61f 35 fields · synced May 30, 2026