RestoreX

Basic Information

• Brand Name: RestoreX
• Primary DI: 00860001453805
• Version / Model: 117
• Catalog Number: 117
• Company Name: PATHRIGHT MEDICAL INC.
• Labeler DUNS: 092965880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 1
• Public Version Date: 2020-10-02
• Public Version Status: New
• Public Device Record Key: a0b234e6-34c1-4a27-af89-b06c02f57bc5

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQI	Orthosis, Limb Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46340	Penile traction splint	A mechanical device worn on the penis typically for gradual penile lengthening or for the non-surgical correction of penile curvature (Peyronie's disease); it may be used after plastic surgery to the penis (phalloplasty). It operates on the principle of traction and typically consists of a base-ring that rests against the pubic bone, a penis head holder, and expandable rods that can exert a constant load between the root and the head of the penis; it may have elements to create an angular force. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001453805	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]