Identity
- Trade Name
- PRECICE Screws FDA UDI
- Generic Name
- Long bone distraction intramedullary nail, magnetic FDA UDI
- Device Name
- 5.0 mm X 20 mm Locking Screw, Fully Threaded FDA UDI
- Model / Reference
- TSA5-020 FDA UDI
- Description
- 5.0 mm X 20 mm Locking Screw, Fully Threaded FDA UDI
Identifiers
- Catalog Number
- TSA5-020 FDA UDI
- Primary DI / UDI-DI
- 00195377168689 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Long bone distraction intramedullary nail, magnetic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.0 Millimeter FDA UDI
PRECICE Screws by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- NuVasive Specialized Orthopedics, Inc.
Sources (1)
- FDA UDI 9e893f08-879b-4d27-a70d-919479790652 37 fields · synced Jun 1, 2026