FDA.reportPublic FDA data

Torosa

Primary DI
05708932470834
Brand
Torosa
Company
Coloplast A/S
Model
450-1327
Catalog number
450-1327
Device description
Saline Filled Testicular Prosthesis
Published
2014-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAFProsthesis, Testicular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAFProsthesis, TesticularGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020003007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020003007COLOPLAST SALINE-FILLED TESTICULAR PROSTHESISColoplast Corp.2002-07-19FAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932470834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932470834057089324708345708932470834

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002583476urology@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05701780462129SenSura Mio Click13656136562026-11-02
05701780462136SenSura Mio Click13657136572026-11-02
05701780462143SenSura Mio Click13658136582026-11-02
05701780462150SenSura Mio Click13659136592026-11-02
05708932588942Freedom Clear5057415057412022-12-06
05708932957847Freedom Clear5057315057312022-12-06
05708932125338SpeediCath Flex Coude Pro20012200122019-07-12
05708932125369SpeediCath Flex Coude Pro20014200142019-07-12
05701780348317Luja Soft20171201712026-10-01
05701780348348Luja Soft20172201722026-10-01
05701780348379Luja Soft20174201742026-10-01
05701780348409Luja Soft20176201762026-10-01
05701780265058Biatain Adhesive348834882026-08-27
05708932787109Titan PrimeDS3918DS39182026-08-14
05708932787116Titan PrimeDS3920DS39202026-08-14
05708932787123Titan PrimeDS3922DS39222026-08-14
05708932787130Titan Prime5400055400052026-08-14
05708932787147Titan Prime5400105400102026-08-14
05708932787888Titan Prime5400155400152026-08-14
05708932787925Titan Prime5400205400202026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708932470797TorosaColoplast A/SFAF2014-07-21
05708932470810TorosaColoplast A/SFAF2014-07-21
05708932470858TorosaColoplast A/SFAF2014-07-21