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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 depth gauge, reusable FDA UDI
- Device Name
- Orthopedic surgical instrument (screw gauge) - for use with the intramedullary limb lengthening system FDA UDI
- Model / Reference
- PSG1-000 FDA UDI
- Description
- Orthopedic surgical instrument (screw gauge) - for use with the intramedullary limb lengthening system FDA UDI
Identifiers
- Catalog Number
- PSG1-000 FDA UDI
- Primary DI / UDI-DI
- 00812258026615 FDA UDI
- FDA Product Code
- HTJ FDA UDI
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4300 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
Category: Surgical depth gauge, reusable
PRECICE® Intramedullary Limb Lengthening System Instrument by NuVasive Specialized Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Surgical depth gauge, reusable.
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- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · 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 I | Pending data |
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Manufacturer
- Manufacturer
- NuVasive Specialized Orthopedics, Inc.
Sources (1)
- FDA UDI 1835f1a9-5bb8-4f7a-ad6b-aced1b5a1762 36 fields · synced May 31, 2026