Identity
- Trade Name
- Scarlet AL-T Instruments FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- SMOOTH TRIAL Small FDA UDI
- Model / Reference
- SPE-US S5 12-N FDA UDI
- Description
- SMOOTH TRIAL Small FDA UDI
Identifiers
- Catalog Number
- SPE-US S5 12-N FDA UDI
- Primary DI / UDI-DI
- 07640185348554 FDA UDI
- FDA Product Code
- OVD FDA UDIMAX FDA UDI
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
Dimensions & Sizes
- Size
- Height — 12 Millimeter FDA UDIAngle — 15 degree FDA UDI
Category: Spinal implant trial
Scarlet AL-T Instruments by Spineart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ROI-A — Ldr Spine USA · Class II
- IdentiTi — ALPHATEC SPINE, INC. · 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
- Spineart
Sources (1)
- FDA UDI 7cdb299f-43fe-4a51-bf4f-faf3df2d01e3 35 fields · synced May 30, 2026