Torosa

Basic Information

• Brand Name: Torosa
• Primary DI: 05708932470797
• Version / Model: 450-1323
• Catalog Number: 450-1323
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-07-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b32f0f65-744c-426b-b423-5a91c2eeb2bd

Device Description

Saline Filled Testicular Prosthesis

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAF	Prosthesis, Testicular	Gastroenterology, Urology	876.3750	3

GMDN Terms

Code	Name	Definition	Implantable	Status
35277	Testicle prosthesis	A device formed in the shape of a testis intended to be implanted in the scrotum to provide the cosmetic appearance of a testicle. It has an aesthetic role and helps to prevent psychogenic sequelae. The device may be made of synthetic polymer (e.g., silicone rubber, or made of a silicone envelope filled with silicone oil), or it may be made of a metallic material.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05708932470797	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P020003	007

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Extra Small

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of sunlight