Identity
- Trade Name
- Radiolucent Instrument Set EUDAMEDFDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
- Device Name
- Surgical Instrument Sets EUDAMEDRadiolucent Instrument Set FDA UDI
- Model / Reference
- 400091 EUDAMEDFDA UDI
- Description
- Radiolucent Instrument Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855369008941 EUDAMEDFDA UDI
- Basic UDI-DI
- 081005552iFuseInstSetML EUDAMED
- FDA Product Code
- OJH FDA UDI
- EMDN Code
- L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Medical Purpose
- Surgical instrument sets for placing or removing SI-BONE implants EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Radiolucent Instrument Set by Si-Bone Inc. — Class I — 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 | 081005552iFuseInstSetML | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SI-BONE, Inc.
- EUDAMED SRN
- US-PR-000044785
Sources (2)
- EUDAMED 0b2d0156-8594-4ddc-9157-2373105bcf7a 61 fields · synced May 30, 2026
- FDA UDI da5bcf95-bb07-4f98-bff7-e7fb50ffd994 34 fields · synced May 30, 2026