Titan 519300

GUDID 05701780278034

Coloplast A/S

Inflatable penile prosthesis

• Primary Device ID: 05701780278034
• NIH Device Record Key: 3b777a46-976e-4f64-b66c-9c6e1197c05e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan
• Version Model Number: 519300
• Catalog Number: 519300
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05701780278034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000006

FDA Product Code

• FHW: Device, impotence, mechanical/hydraulic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-06
• Device Publish Date: 2025-07-29

On-Brand Devices [Titan]

• 05708932661416: Titan Assembly Kit with Turbo™ Disposable Furlow Insertion Tool
• 05708932539203: Titan® Touch Scrotal Zero Degree Angle Cylinder Set with Pump
• 05708932539197: Titan® Touch Scrotal Zero Degree Angle Cylinder Set with Pump
• 05708932539180: Titan® Touch Scrotal Zero Degree Angle Cylinder Set with Pump
• 05708932539173: Titan® Touch Scrotal Zero Degree Angle Cylinder Set with Pump
• 05708932539166: Titan® Touch Scrotal Zero Degree Angle Cylinder Set with Pump
• 05708932539142: Titan® Touch Infrapubic Zero Degree Angle Cylinder Set with Pump
• 05708932539135: Titan® Touch Infrapubic Zero Degree Angle Cylinder Set with Pump
• 05708932539128: Titan® Touch Infrapubic Zero Degree Angle Cylinder Set with Pump
• 05708932539111: Titan® Touch Infrapubic Zero Degree Angle Cylinder Set with Pump
• 05708932539104: Titan® Touch Infrapubic Zero Degree Angle Cylinder Set with Pump
• 05708932539098: Titan® Touch Scrotal Zero Degree Angle Cylinder Set with Pump - Narrow
• 05708932539081: Titan® Touch Scrotal Zero Degree Angle Cylinder Set with Pump - Narrow
• 05708932539074: Titan® Touch Infrapubic Zero Degree Angle Cylinder Set with Pump - Narrow
• 05708932539067: Titan® Touch Infrapubic Zero Degree Angle Cylinder Set with Pump - Narrow
• 05708932533966: Titan Touch Pump
• 05708932532754: Scrotal OTR Zero Degree Angle Cylinder Set with Pump - Narrow
• 05708932532747: Scrotal OTR Zero Degree Angle Cylinder Set with Pump - Narrow
• 05708932532730: Infrapubic OTR Zero Degree Angle Cylinder Set with Pump - Narrow
• 05708932532723: Infrapubic OTR Zero Degree Angle Cylinder Set with Pump - Narrow
• 05708932532716: Infrapubic Zero Degree Angle Cylinder Set with Pump - Narrow
• 05708932532709: Scrotal Zero Degree Angle Cylinder Set with Pump - Narrow
• 05708932532693: Infrapubic Zero Degree Angle Cylinder Set with Pump - Narrow
• 05708932532686: Infrapubic Zero Degree Angle Cylinder Set with Pump - Narrow
• 05708932527354: Narrow Base Rear Tip Extenders
• 05708932519847: Assembly Kit
• 05708932487702: Scrotal OTR Zero Degree Angle Cylinder Set with Pump
• 05708932487689: Scrotal OTR Zero Degree Angle Cylinder Set with Pump
• 05708932487665: Scrotal OTR Zero Degree Angle Cylinder Set with Pump
• 05708932487641: Scrotal OTR Zero Degree Angle Cylinder Set with Pump
• 05708932487580: Infrapubic OTR Zero Degree Angle Cylinder Set with Pump
• 05708932487566: Infrapubic OTR Zero Degree Angle Cylinder Set with Pump
• 05708932487542: Infrapubic OTR Zero Degree Angle Cylinder Set with Pump
• 05708932487528: Infrapubic OTR Zero Degree Angle Cylinder Set with Pump
• 05708932487467: Cylinder Set - zero angle
• 05708932487443: Cylinder Set - zero angle
• 05708932487429: Cylinder Set - zero angle
• 05708932487382: Scrotal Zero Degree Angle Cylinder Set with Pump
• 05708932487368: Scrotal Zero Degree Angle Cylinder Set with Pump
• 05708932487344: Scrotal Zero Degree Angle Cylinder Set with Pump
• 05708932487320: Scrotal Zero Degree Angle Cylinder Set with Pump
• 05708932487306: Scrotal Zero Degree Angle Cylinder Set with Pump
• 05708932487283: Scrotal Zero Degree Angle Cylinder Set with Pump
• 05708932487269: Infrapubic Zero Degree Angle Cylinder Set with Pump
• 05708932487245: Infrapubic Zero Degree Angle Cylinder Set with Pump
• 05708932487221: Infrapubic Zero Degree Angle Cylinder Set with Pump
• 05708932487184: Infrapubic Zero Degree Angle Cylinder Set with Pump
• 05708932487160: Infrapubic Zero Degree Angle Cylinder Set with Pump
• 05708932487146: Infrapubic Zero Degree Angle Cylinder Set with Pump
• 05708932473927: CL Reservoir