FREMAP Electrode DCNE-01-05X

GUDID 90841823108480

AD-TECH MEDICAL INSTRUMENT CORPORATION

Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode
Primary Device ID90841823108480
NIH Device Record Key6632dbc8-839a-49e7-9404-a8f210998ccb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFREMAP Electrode
Version Model NumberDCNE-01-05X
Catalog NumberDCNE-01-05X
Company DUNS174813410
Company NameAD-TECH MEDICAL INSTRUMENT CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Device Identifiers

Device Issuing AgencyDevice ID
GS100841823108487 [Primary]
GS190841823108480 [Package]
Contains: 00841823108487
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETNSTIMULATOR, NERVE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-03

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