Touch II

GUDID 00852598007042

Battery Vacuum Pump

AUGUSTA MEDICAL SYSTEMS, L.L.C.

Penile vacuum device
Primary Device ID00852598007042
NIH Device Record Key12daa94a-a3da-4b61-81d0-de18991a0999
Commercial Distribution StatusIn Commercial Distribution
Brand NameTouch II
Version Model NumberBattery Vacuum Pump
Company DUNS052255606
Company NameAUGUSTA MEDICAL SYSTEMS, L.L.C.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-827-8382
Emailsomatherapy@augustams.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852598007042 [Primary]

FDA Product Code

LKYDevice, External Penile Rigidity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-07-17

On-Brand Devices [Touch II]

00852598007097External Penile Rigidity Device that contains kit bag, battery vacuum pump, tension systems, cyl
00852598007042Battery Vacuum Pump

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