Home GUDID B598GMVTS0001 Gesiva Medical
Primary DI B598GMVTS0001
Brand Gesiva Medical
Company GESIVA MEDICAL LLC
Model Vacuum Therapy System
Published 2017-10-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name LKY Device, External Penile Rigidity
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LKY Device, External Penile Rigidity Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B598GMVTS0001 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Penile vacuum device A 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.
Regulatory Flags# DUNS number 068245824 Device count 1 Premarket exempt true Kit true Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B598GMXLC00020 Gesiva Medical Extra Large Clear Plastic Cylinder 2020-07-17 B598GMTRK0002 Gesiva Medical Tension Ring Kit 2020-04-09 B598GMMHT0001 Gesiva Medical Medium High Tension Ring 2018-01-09 B598GMCC0001 Gesiva Medical Carrying Case 2018-01-09 B598GMCI0001 Gesiva Medical Comfort Insert 2018-01-09 B598GMCPC0001 Gesiva Medical Clear Plastic Cylinder 2018-01-09 B598GMLHT0001 Gesiva Medical Large High Tension Ring 2018-01-09 B598GMLST0001 Gesiva Medical Large Standard Tension Ring 2018-01-09 B598GMMST0001 Gesiva Medical Medium Standard Tension Ring 2018-01-09 B598GMTRL0001 Gesiva Medical Tension Ring Loader 2018-01-09 B598GMVPH0001 Gesiva Medical Vacuum Pump Handle 2018-01-09
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