RestoreX 117

GUDID 00860001453805

RestoreX Kit - penile traction therapy device for the treatment of Peyronie's disease. Contains RestoreX device, extension rods, self-adherent wrap, Instructions for Use

PATHRIGHT MEDICAL INC.

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• Primary Device ID: 00860001453805
• NIH Device Record Key: a0b234e6-34c1-4a27-af89-b06c02f57bc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RestoreX
• Version Model Number: 117
• Catalog Number: 117
• Company DUNS: 092965880
• Company Name: PATHRIGHT MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com
• Phone: 877-228-5147
• Email: support@restorex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001453805 [Primary]

FDA Product Code

• IQI: Orthosis, Limb Brace

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: 2020-10-02
• Device Publish Date: 2020-09-24