External Remote Controller EAD-P1-010

GUDID 00856719002039

External remote controller - for use with the PRECICE intramedullary limb lengthening system

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Distraction plate/rod controller 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 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: 00856719002039
• NIH Device Record Key: 5a7a143c-66c8-4ec8-919d-d0bee27080ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: External Remote Controller
• Version Model Number: P003
• Catalog Number: EAD-P1-010
• Company DUNS: 837845234
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195377000484 [Package]; Package: Pelican Case [1 Units]; In Commercial Distribution
GS1	00856719002039 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2015-10-15

On-Brand Devices [External Remote Controller]

• 00812258022877: External remote controller - for use with the PRECICE intramedullary limb lengthening system
• 00812258022839: External remote controller - for use with the MAGEC spinal bracing and distraction system
• 00887517001344: External remote controller - for use with the PRECICE intramedullary limb lengthening system
• 00856719002220: External remote controller - for use with the FREEDOM residual limb lengthening system
• 00856719002107: External remote controller - for use with the MAGEC spinal bracing and distraction system
• 00856719002039: External remote controller - for use with the PRECICE intramedullary limb lengthening system
• 00887517014979: ERC-for use with PRECICE System