← Back to catalogue
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 retractor FDA UDI
- Device Name
- Orthopedic surgical instrument (soft tissue protector) - for use with the intramedullary limb lengthening system FDA UDI
- Model / Reference
- DSD2-035 FDA UDI
- Description
- Orthopedic surgical instrument (soft tissue protector) - for use with the intramedullary limb lengthening system FDA UDI
Identifiers
- Catalog Number
- DSD2-035 FDA UDI
- Primary DI / UDI-DI
- 00812258026455 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Orthopaedic retractor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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 retractor
PRECICE® Intramedullary Limb Lengthening System Instrument by NuVasive Specialized Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Orthopaedic retractor.
- SeaSpine Spacer System - Pacifica — SeaSpine Orthopedics Corporation · Class I
- Coral — SeaSpine Orthopedics Corporation · Class I
- Unicondylar Interpositional Spacer — Zimmer, Inc. · Class II
- OrthoMedFlex — ORTHOMEDFLEX LLC · Class I
- NewPort — SeaSpine Orthopedics Corporation · Class I
- No Brand — Smith & Nephew, Inc. · Class I
- OrthoMedFlex — ORTHOMEDFLEX LLC · Class I
- NewPort — SeaSpine Orthopedics 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NuVasive Specialized Orthopedics, Inc.
Sources (1)
- FDA UDI 4d2f6e57-288f-4e0e-bbe2-cbb21ccf7007 36 fields · synced May 31, 2026