Genesis 91-9511SC

GUDID 05708932324748

Malleable Penile Prosthesis

Coloplast A/S

Rigid penile prosthesis

• Primary Device ID: 05708932324748
• NIH Device Record Key: 2aab0596-b065-4aa9-bf19-64f89d443ced
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesis
• Version Model Number: 91-9511SC
• Catalog Number: 91-9511SC
• 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: +1(800)258-3476
• Email: urology@coloplast.com

Device Dimensions

• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932324748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040959

FDA Product Code

• FAE: PROSTHESIS, PENILE

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: 2015-10-28

On-Brand Devices [Genesis]

• 05708932324809: Malleable Penile Prosthesis
• 05708932324748: Malleable Penile Prosthesis
• 05708932324687: Malleable Penile Prosthesis