Torosa 450-1323

GUDID 05708932470797

Saline Filled Testicular Prosthesis

Coloplast A/S

Testicle prosthesis

• Primary Device ID: 05708932470797
• NIH Device Record Key: b32f0f65-744c-426b-b423-5a91c2eeb2bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Torosa
• Version Model Number: 450-1323
• Catalog Number: 450-1323
• 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: 8002583476
• Email: urology@coloplast.com

Device Dimensions

• 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	05708932470797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020003

FDA Product Code

• FAF: Prosthesis, Testicular

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: 2014-07-21

On-Brand Devices [Torosa]

• 05708932470858: Saline Filled Testicular Prosthesis
• 05708932470834: Saline Filled Testicular Prosthesis
• 05708932470810: Saline Filled Testicular Prosthesis
• 05708932470797: Saline Filled Testicular Prosthesis