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PRECICE® Intramedullary Limb Lengthening System Instrument
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- PRECICE® Intramedullary Limb Lengthening System Instrument FDA UDI
- Generic Name
- Orthopaedic implant driver FDA UDI
- Device Name
- Orthopedic Manual surgical instrument (Screw Driver) FDA UDI
- Model / Reference
- DRB1-269 FDA UDI
- Description
- Orthopedic Manual surgical instrument (Screw Driver) FDA UDI
Identifiers
- Catalog Number
- DRB1-269 FDA UDI
- Primary DI / UDI-DI
- 00812258021849 FDA UDI
- FDA Product Code
- HXX FDA UDI
- GMDN Term
- Orthopaedic implant driver FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic implant driver
PRECICE® Intramedullary Limb Lengthening System Instrument by NuVasive Specialized Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID
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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 I | Pending data |
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Manufacturer
- Manufacturer
- NuVasive Specialized Orthopedics, Inc.
Sources (1)
- FDA UDI 8d6398b2-6cfb-4aa9-a50f-13f9b0e3d6af 36 fields · synced Jun 8, 2026