Titan® EN8818

GUDID 05708932072601

Titan Narrow Infrapubic Zero Angle 18CM

Coloplast A/S

Inflatable penile prosthesis

• Primary Device ID: 05708932072601
• NIH Device Record Key: 9f597e07-0f8a-4541-b323-7d0e074f5934
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan®
• Version Model Number: Titan
• Catalog Number: EN8818
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932072601 [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: 2017-10-16

On-Brand Devices [Titan®]

• 05708932072649: Titan Narrow Scrotal Zero Angle 18CM
• 05708932072632: Titan Narrow Scrotal Zero Angle 16CM
• 05708932072601: Titan Narrow Infrapubic Zero Angle 18CM
• 05708932072595: Titan Narrow Infrapubic Zero Angle 16CM
• 05708932072564: Titan Touch Narrow Base Scrotal Zero Angle 18cm
• 05708932072557: Titan Touch Narrow Base Scrotal Zero Angle 16cm
• 05708932072526: Titan Touch Narrow Base Infrapubic Zero Angle 18cm
• 05708932072519: Titan Touch Narrow Base Infrapubic Zero Angle 16cm