DERMADRY FPRD-004

GUDID 00877067000010

DERMADRY TOTAL Tap Water Iontophoresis Device for treatment of hands, feet and underarms

Dermadry Laboratories Inc

Hyperhidrosis iontophoresis system
Primary Device ID00877067000010
NIH Device Record Key5b62255b-41c2-43d6-89cc-05d15ed80ab9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDERMADRY
Version Model NumberTOTAL
Catalog NumberFPRD-004
Company DUNS203532858
Company NameDermadry Laboratories Inc
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100877067000010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EGJDevice, Iontophoresis, Other Uses

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-25
Device Publish Date2020-03-17

On-Brand Devices [DERMADRY]

00877067000034DERMADRY UNDERARMS Tap Water Iontophoresis Device for treatment of underarms
00877067000027DERMADRY HANDS AND FEET Tap Water Iontophoresis Device for treatment of hands and feet
00877067000010DERMADRY TOTAL Tap Water Iontophoresis Device for treatment of hands, feet and underarms

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