Identity
- Trade Name
- PRECICE® Instruments FDA UDI
- Generic Name
- Femur intramedullary nail FDA UDI
- Device Name
- Orthopedic surgical instrument - Targeting Arm Troch Femur, Short FDA UDI
- Model / Reference
- PGA1-003 FDA UDI
- Description
- Orthopedic surgical instrument - Targeting Arm Troch Femur, Short FDA UDI
Identifiers
- Catalog Number
- PGA1-003 FDA UDI
- Primary DI / UDI-DI
- 00812258028862 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Femur intramedullary nail FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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
Category: Femur intramedullary nail
PRECICE® Instruments by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femur intramedullary nail.
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- 130° Ga-mma Nail — Auxein Medical Private Limited · Class II
- ARIX Femur Nail System — Jeil Medical Corporation · Class II
- INTERTAN — Smith & Nephew, Inc. · Class II
- TRIGEN — Smith & Nephew, 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
- NuVasive Specialized Orthopedics, Inc.
Sources (1)
- FDA UDI cbf27779-6ee7-4156-8deb-bab987b7a3c5 36 fields · synced May 31, 2026