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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
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Orthopedic Manual surgical instrument (Non-Ratcheting T-Handle, Ratcheting Quick Connect Handle) FDA UDI
- Model / Reference
- THD2-000 FDA UDI
- Description
- Orthopedic Manual surgical instrument (Non-Ratcheting T-Handle, Ratcheting Quick Connect Handle) FDA UDI
Identifiers
- Catalog Number
- THD2-000 FDA UDI
- Primary DI / UDI-DI
- 00812258026486 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting 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: Surgical instrument handle, non-torque-limiting
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 19529225-033d-49bf-bd2a-8445c4a28e3b 36 fields · synced May 31, 2026