FDA.reportPublic FDA data

Genesis

Primary DI
05708932324748
Brand
Genesis
Company
Coloplast A/S
Model
91-9511SC
Catalog number
91-9511SC
Device description
Malleable Penile Prosthesis
Published
2015-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAEPROSTHESIS, PENILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAEProsthesis, PenileGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040959000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040959000MENTOR GENESIS PENILE PROSTHESISMentor Corp.2004-10-29FAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932324748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932324748057089323247485708932324748

GMDN Terms#

Term, Definition table
TermDefinition
Rigid penile prosthesisA rigid or semi-rigid sterile rod or cylinder-like device intended to be surgically implanted in the corpora cavernosa of the penis in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve permanent penile tumescence and rigidity adequate for vaginal intercourse. This device is available in a variety of designs and materials such as: 1) a flexible solid rod of polymer; 2) a flexible polymer or silicone cylinder with an internal silver (Ag) coil core; or 3) a single- or multiple-hinged rod enabling the user to position the penis downwards for better concealment under clothing.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter11Millimeter

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
+1(800)258-3476urology@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
00850299008443RIGI10 Rigicon, Inc.FAE2024-01-26
00850299008450RIGI10Rigicon, Inc.FAE2024-01-26
00850299008467RIGI10 Rigicon, Inc.FAE2024-01-26
00850299008474RIGI10Rigicon, Inc.FAE2024-01-26
00850299008481RIGI10 Rigicon, Inc.FAE2024-01-26
00850299008009RIGI10™Rigicon, Inc.FAE2019-12-12
00850299008016RIGI10™Rigicon, Inc.FAE2019-12-12
00850299008023RIGI10™Rigicon, Inc.FAE2019-12-12
00850299008030RIGI10™Rigicon, Inc.FAE2019-12-12
00850299008047RIGI10™Rigicon, Inc.FAE2019-12-12
08714729979340TACTRABOSTON SCIENTIFIC CORPORATIONFAE2019-05-06
08714729979357TACTRABOSTON SCIENTIFIC CORPORATIONFAE2019-05-06
08714729979364TACTRABOSTON SCIENTIFIC CORPORATIONFAE2019-05-06
00878953000497SizerAMERICAN MEDICAL SYSTEMS, INC.FAE2016-09-24
00878953000503SizerAMERICAN MEDICAL SYSTEMS, INC.FAE2016-09-24
00878953004044Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004051Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004068Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004075Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004082Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004099Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004105Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004112Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953005201Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005218Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005225Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005232Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005249Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005256Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005270Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12