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PRECICE® Intramedullary Limb Lengthening System Instrument
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- PRECICE® Intramedullary Limb Lengthening System Instrument FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Orthopedic surgical instrument (drill guide) - for use with the intramedullary limb lengthening system FDA UDI
- Model / Reference
- AGB2-000 FDA UDI
- Description
- Orthopedic surgical instrument (drill guide) - for use with the intramedullary limb lengthening system FDA UDI
Identifiers
- Catalog Number
- AGB2-000 FDA UDI
- Primary DI / UDI-DI
- 00812258026400 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Surgical drill guide, reusable 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: Surgical drill guide, reusable
PRECICE® Intramedullary Limb Lengthening System Instrument by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Surgical drill guide, reusable.
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- Hintermann Series — Dt Medtech, LLC · 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 II | Pending data |
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Manufacturer
- Manufacturer
- NuVasive Specialized Orthopedics, Inc.
Sources (1)
- FDA UDI 89e47bef-7327-46ee-9ff8-04debd5feb61 36 fields · synced Jun 8, 2026