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SANTIS™CAN. REDUC EXTRA LONG POLYAXIAL PEDICLE SCREW/Dia.5.5mm/Lng.40mm -STER
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SANTIS™CAN. REDUC EXTRA LONG POLYAXIAL PEDICLE SCREW/Dia.5.5mm/Lng.40mm -STER FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, sterile FDA UDI
- Device Name
- SANTIS™CAN. REDUC EXTRA LONG POLYAXIAL PEDICLE SCREW/Dia.5.5mm/Lng.40mm -STERILE FDA UDI
- Model / Reference
- 901-5540-S FDA UDI
- Description
- SANTIS™CAN. REDUC EXTRA LONG POLYAXIAL PEDICLE SCREW/Dia.5.5mm/Lng.40mm -STERILE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640159552505 FDA UDI
- FDA Product Code
- NKB FDA UDIMNI FDA UDIMNH FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Bone-screw internal spinal fixation system, sterile
SANTIS™CAN. REDUC EXTRA LONG POLYAXIAL PEDICLE SCREW/Dia.5.5mm/Lng.40mm -STER by Lanterna Medical Technologies — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Bone-screw internal spinal fixation system, sterile.
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- Mont Blanc MIS Spinal Systems — Spineway SA · Class II
- Mont Blanc Spinal Systems — Spineway SA · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lanterna Medical Technologies
Sources (1)
- FDA UDI 9e5a7779-941c-453c-8c55-d57cdbf40d38 34 fields · synced May 30, 2026