FDA.reportPublic FDA data

Torosa

Primary DI
05708932470797
Brand
Torosa
Company
Coloplast A/S
Model
450-1323
Catalog number
450-1323
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
05708932470797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932470797057089324707975708932470797

GMDN Terms#

Term, Definition table
TermDefinition
Testicle prosthesisA 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.

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
05708932487047Peristeen29125291252016-09-20
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30
05701780437066SenSura Mio Convex1373201373202026-04-30
05701780437127SenSura Mio Convex1373301373302026-04-30
05701780437561SenSura Mio Convex1680101680102026-04-30
05701780438384SenSura Mio Convex1680501680502026-04-30
05701780439923SenSura Mio Convex1682101682102026-04-30
05701780440462SenSura Mio Convex1682201682202026-04-30
05701780440875SenSura Mio Convex1682301682302026-04-30
05701780441292SenSura Mio Convex1682501682502026-04-30
05701780441926SenSura Mio Convex1682601682602026-04-30
05701780442572SenSura Mio Convex1682701682702026-04-30
05701780443074SenSura Mio Convex1683001683002026-04-30
05701780443371SenSura Mio Convex1683101683102026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708932470810TorosaColoplast A/SFAF2014-07-21
05708932470834TorosaColoplast A/SFAF2014-07-21
05708932470858TorosaColoplast A/SFAF2014-07-21