Identity
- Trade Name
- Regatta Lateral System FDA UDI
- Generic Name
- Bone file FDA UDI
- Device Name
- Lateral Box Cutter, 6x18mm FDA UDI
- Model / Reference
- 95-6616 FDA UDI
- Description
- Lateral Box Cutter, 6x18mm FDA UDI
Identifiers
- Catalog Number
- 95-6616 FDA UDI
- Primary DI / UDI-DI
- 10889981162610 FDA UDI
- FDA Product Code
- FZT FDA UDI
- GMDN Term
- Bone file FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA 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
Yes
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
Category: Bone file
Regatta Lateral System by SeaSpine Orthopedics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Sklar® — Sklar Corporation · Class I
- Sklar® — Sklar Corporation · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI 1c189098-cf52-4491-b769-76d7b26d32e4 36 fields · synced Jun 8, 2026