Identity
- Trade Name
- PRECICE® Specialty Targeting Instrument Set FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Surgical instrument tray containing orthopedic surgical instruments - for use with the intramedullary limb lengthening rod system FDA UDI
- Model / Reference
- ITA4-000 FDA UDI
- Description
- Surgical instrument tray containing orthopedic surgical instruments - for use with the intramedullary limb lengthening rod system FDA UDI
Identifiers
- Catalog Number
- ITA4-000 FDA UDI
- Primary DI / UDI-DI
- 00812258026394 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: General internal orthopaedic fixation system implantation kit
PRECICE® Specialty Targeting Instrument Set by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 cdf04e59-c295-43e6-a597-3b13c7b633b6 36 fields · synced Jun 1, 2026