FDA.reportPublic FDA data

Elite Custom Premium

Primary DI
00852598007158
Brand
Elite Custom Premium
Company
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Model
External Penile Rigidity Device
Device description
External Penile Rigidity Device that contains kit bag, manual vacuum pump, battery vacuum pump,constriction rings, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
Published
2017-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKYDevice, External Penile Rigidity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKYDevice, External Penile RigidityGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852598007158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852598007158008525980071588525980071580852598007158

GMDN Terms#

Term, Definition table
TermDefinition
Penile vacuum deviceA device that is applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is typically a two-component device consisting of: 1) a manually-operated, vacuum pump/sleeve which is applied over the flaccid penis and used to create a vacuum to achieve tumescence through an up and down movement along a vacuum tube; and 2) a constriction ring used in conjunction with the pump and placed upon the penis to maintain the erection. The ring remains on the penis for a recommended period of time. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-827-8382somatherapy@augustams.com

Regulatory Flags#

DUNS number
052255606
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852598007233SureFit ZConstriction Ring2017-07-17
00852598007288SureRelease EnhancedConstriction Ring2017-07-17
00852598007295SureRelease StandardConstriction Ring2017-07-17
00852598007004Response IIManual Vacuum Pump2017-07-17
00852598007011Soma Therapy OTCManual Vacuum Pump2017-07-17
00852598007028Elite CustomManual Vacuum Pump2017-07-17
00852598007035Somaerect StfManual Vacuum Pump2017-07-17
00852598007042Touch IIBattery Vacuum Pump2017-07-17
00852598007059Soma Therapy OTC PlusBattery Vacuum Pump2017-07-17
00852598007066Somaerect Stf PlusBattery Vacuum Pump2017-07-17
00852598007073Elite Custom PlusBattery Vacuum Pump2017-07-17
00852598007080Response IIExternal Penile Rigidity Device2017-07-17
00852598007097Touch IIExternal Penile Rigidity Device2017-07-17
00852598007103Soma Therapy OTCExternal Penile Rigidity Device2017-07-17
00852598007110Soma Therapy OTC PlusExternal Penile Rigidity Device2017-07-17
00852598007127Soma Therapy OTC PremiumExternal Penile Rigidity Device2017-07-17
00852598007134Elite CustomExternal Penile Rigidity Device2017-07-17
00852598007141Elite Custom PlusExternal Penile Rigidity Device2017-07-17
00852598007165Somaerect StfExternal Penile Rigidity Device2017-07-17
00852598007172Somaerect Stf PlusExternal Penile Rigidity Device2017-07-17

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Primary DI, Brand, Company table
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00850076064037Pipedream Beginner's Power Pump - Black PD Products, LLCLKY2026-05-01
00850076064044Pump Worx Max Boost - Black PD Products, LLCLKY2026-05-01
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00850076064068Pump Worx Beginner's Vibrating Pump - Clear/Black PD Products, LLCLKY2026-05-01
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00850076064105Pump Worx Max Boost - Blue PD Products, LLCLKY2026-05-01
00850076064112Pump Worx Silicone Power Pump - Blue PD Products, LLCLKY2026-05-01
00850076064129Pump Worx Silicone Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064136Pump Worx Beginner's Power Pump - Purple PD Products, LLCLKY2026-05-01
00850076064143Pump Worx Beginner's Power Pump - Clear PD Products, LLCLKY2026-05-01
00850076064150Classix Power PumpPD Products, LLCLKY2026-05-01
00850076064167Pump Worx Beginner's Power Pump - Red PD Products, LLCLKY2026-05-01
00850076064174Classix Vibrating Power Pump - ClearPD Products, LLCLKY2026-05-01
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