Precice External Remote Controller SW0011

GUDID 00195377097309

PRECICE Prescription Program

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control

• Primary Device ID: 00195377097309
• NIH Device Record Key: 814f4666-16d5-4c0f-ba1a-c2f4a73593cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precice External Remote Controller
• Version Model Number: SW0011
• Catalog Number: SW0011
• Company DUNS: 837845234
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195377097309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131490

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-08
• Device Publish Date: 2021-10-29

On-Brand Devices [Precice External Remote Controller]

• 00887517059499: PRECICE ERC 4P Shipping Pkg GER
• 00887517059444: PRECICE ERC 4P Shipping Pkg AU
• 00887517059437: PRECICE ERC 4P Shipping Pkg EU
• 00195377083302: PRECICE ERC 4P
• 00195377024343: PRECICE ERC 4P Shipping Pkg UK
• 00887517990105: Precice ERC 3P
• 00887517945327: PRECICE ERC 3P Shipping Pkg AU
• 00887517945310: PRECICE ERC 3P Shipping Pkg EU
• 00887517945303: PRECICE ERC 3P Shipping Pkg UK
• 00195377099105: Precice ERC 2P
• 00195377097309: PRECICE Prescription Program