Titan ES8911

GUDID 05708932487283

Scrotal Zero Degree Angle Cylinder Set with Pump

Coloplast A/S

Inflatable penile prosthesis

• Primary Device ID: 05708932487283
• NIH Device Record Key: 690d2ee6-730d-4d90-9c97-581e12237db8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan
• Version Model Number: ES8911
• Catalog Number: ES8911
• 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: 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: 8002583476
• Email: urology@coloplast.com

Device Dimensions

• Length: 11 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	05708932487283 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-19

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