FDA.reportPublic FDA data

Encore

Primary DI
10850358007421
Brand
Encore
Company
ENCORE, INC.
Model
44017 UNM - Carton 12
Catalog number
44017 - 12
Device description
44017-UNM- Vacuum Erection Device - Master Carton 12
Published
2019-02-18
Public version status
New
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
10850358007421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085035800742110850358007421

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.

Contacts#

Phone, Email table
PhoneEmail
800-475-3091info@revivepremium.com

Regulatory Flags#

DUNS number
614647725
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850358007407Encore44017 RETNP - Carton 1244017 - 122019-02-18
10850358007414Encore44017 UNB - Carton 1244017 - 122019-02-18
00850358007400Encore44017 RETNP - 3 kits44017 - 32019-02-18
00850358007417Encore44017 UNB - 3 kits44017 - 32019-02-18
00850358007424Encore44017 UNM - 3 kits44017 - 32019-02-18
00850358007004ImpoaidVTU-144010-0012016-09-01
00850358007011EncoreVTU-144010-1002016-09-01
00850358007028ReviveVTU-1440142016-09-01
00850358007035ReviveVTU-E44016-battery2016-09-01
00850358007042EncoreVA VTU-144017-manual2016-09-01
00850358007059EncoreVA VTU-E44017-battery2016-09-01
00850358007066ReviveVTU-E44017-ret2016-09-01
00850358007073ImpoaidVTU-E44019-0012016-09-01
00850358007080EncoreDeluxe VTU-E44020-0012016-09-01
00850358007097ImpoaidRing Kit44023-0012016-09-01
00850358007103EncoreErect Pro Plus Manual and Battery 40372016-11-12
00850358007110EncoreErect Pro Battery40362016-11-12
00850358007127EncoreErect Pro Manual 40352016-11-12
00850358007134EncoreAMERICAN CONE1100-001USCONE2017-07-25
00850358007141EncoreACRYLIC RING EJECTOR1100-10-0012017-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
00850076064181Pump Worx Beginner's Power Pump - Smoke/Black PD Products, LLCLKY2026-05-01
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00850076064204Pump Worx Max-Width Penis Enlarger - Clear/Black PD Products, LLCLKY2026-05-01
00850076064211Pipedream Beginner's Power Pump - Clear PD Products, LLCLKY2026-05-01
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