Restorelle 501520

GUDID 05708932528108

Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - Y Contour™

Coloplast A/S

Pelvic organ prolapse surgical mesh, synthetic polymer

• Primary Device ID: 05708932528108
• NIH Device Record Key: 45f1791f-058f-4845-b9b8-6ed9afaf72f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restorelle
• Version Model Number: 501520
• Catalog Number: 501520
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +1(800)258-3476
• Email: urology@coloplast.com

Device Dimensions

• Length: 24 Centimeter
• Width: 3 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932528108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123914

FDA Product Code

• OTO: Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-22

On-Brand Devices [Restorelle]

• 05708932528108: Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - Y Contour™
• 05708932484084: Direct Fix™ Posterior Polypropylene Mesh
• 05708932484022: Direct Fix™ Anterior Polypropylene Mesh
• 05708932483964: Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - L
• 05708932483896: Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - Y
• 05708932483834: Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - Y
• 05708932483285: Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - XL
• 05708932483223: Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - M