Torosa 450-1325

GUDID 05708932470810

Saline Filled Testicular Prosthesis

Coloplast A/S

Testicle prosthesis
Primary Device ID05708932470810
NIH Device Record Key498565fc-cb9f-407d-af24-eda1d6488d16
Commercial Distribution StatusIn Commercial Distribution
Brand NameTorosa
Version Model Number450-1325
Catalog Number450-1325
Company DUNS305524696
Company NameColoplast A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8002583476
Emailurology@coloplast.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932470810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FAFProsthesis, Testicular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-07-21

On-Brand Devices [Torosa]

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

Trademark Results [Torosa]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TOROSA
TOROSA
79042640 3427210 Live/Registered
Coloplast A/S
2007-07-05

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