FDA.reportPublic FDA data

True-Lock

Primary DI
05708932778701
Brand
True-Lock
Company
Coloplast A/S
Model
550020
Catalog number
550020
Published
2025-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHWDevice, impotence, mechanical/hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHWDevice, Impotence, Mechanical/HydraulicGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000006071

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000006071TITAN INFLATABLE PENILE PROSTHESISColoplast Corp.2000-07-14FHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932778701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932778701057089327787015708932778701

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable penile prosthesisAn inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is available in a variety of designs and materials and typically consists of: 1) one or two inflatable cylinders implanted into the corpora cavernosa of the penis; 2) a subcutaneous manual pump bulb implanted into the scrotum; 3) a reservoir containing fluid (e.g., saline with/without radiopacifier) implanted in the abdomen; and 4) kink-resistant tubing that connect the component parts.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize.

Contacts#

Phone, Email table
PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05701780444026SenSura Mio Convex1683201683202026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708932778671TitanColoplast A/SFHW2025-10-21
05701780278034TitanColoplast A/SFHW2025-07-29
05708932768115Titan ClassicColoplast A/SFHW2024-10-29
05708932768139Titan ClassicColoplast A/SFHW2024-10-29
05708932768153Titan TouchColoplast A/SFHW2024-10-29
05708932768177Titan TouchColoplast A/SFHW2024-10-29
05701780276979TitanColoplast A/SFHW2023-05-11
05701780277006TitanColoplast A/SFHW2023-05-11
05708932072519Titan®Coloplast A/SFHW2017-10-16
05708932072526Titan®Coloplast A/SFHW2017-10-16
05708932072557Titan®Coloplast A/SFHW2017-10-16
05708932072564Titan®Coloplast A/SFHW2017-10-16
05708932072595Titan®Coloplast A/SFHW2017-10-16
05708932072601Titan®Coloplast A/SFHW2017-10-16
05708932072632Titan®Coloplast A/SFHW2017-10-16
05708932072649Titan®Coloplast A/SFHW2017-10-16
05708932661416TitanColoplast A/SFHW2017-06-21
05708932539104TitanColoplast A/SFHW2016-03-29
05708932539166TitanColoplast A/SFHW2016-03-29
00878953000947AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953000954AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953000961AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953000978AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953000985AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953000992AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953001005AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953001012AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953001029AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953001364AMS Ambicor RTE KitBOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953003023Proximal ToolAMERICAN MEDICAL SYSTEMS, INC.FHW2014-09-24