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Blunt pin
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 400425-010Ref 400425-015Ref 500845
Identity
- Trade Name
- O-Arm Pin, 3.1mm, Blunt FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- Blunt pin EUDAMEDO-Arm Pin, 3.1mm, Blunt FDA UDI
- Model / Reference
- 400425-010 EUDAMED400425-015 EUDAMED500845 EUDAMEDFDA UDI
- Description
- O-Arm Pin, 3.1mm, Blunt FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810055523122 EUDAMED00810055522958 EUDAMED00855369008248 EUDAMEDFDA UDI
- Basic UDI-DI
- 081005552BluntPin3C EUDAMED
- Direct Marketing DI
- 00810055523122 EUDAMED00810055522958 EUDAMED00855369008248 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Blunt pin by Si-Bone Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081005552BluntPin3C | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SI-BONE, Inc.
- EUDAMED SRN
- US-MF-000028624
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (4)
- EUDAMED 68efeb6e-89de-4d11-84f6-dd93de7c1290 61 fields · synced Sep 18, 2026
- EUDAMED c528bcb8-ec92-4d60-8163-bea467063270 61 fields · synced May 18, 2026
- EUDAMED 5c39f6c7-6e4e-4a26-a601-eb67218aa2e0 61 fields · synced May 18, 2026
- FDA UDI 1ad7a47d-eaef-4688-8ca5-cef0a427f4ce 34 fields · synced May 27, 2026