Subdural Electrode FG10A-SP10X-000

GUDID 00841823101587

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 ID00841823101587
NIH Device Record Key468084a1-fbc8-40a7-8e0d-d6537668c7fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSubdural Electrode
Version Model NumberFG10A-SP10X-000
Catalog NumberFG10A-SP10X-000
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
GS100841823101587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GYCELECTRODE, CORTICAL

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 Date2016-09-23

On-Brand Devices [Subdural Electrode]

00841823108456ZS08R-GP10X-WW6
00841823108449ZS04R-GP10X-WW6
00841823108388VG05A-IS00X-0KQ
00841823108371VG04A-SS00X-0KP
00841823108364VG04A-IS00X-0KL
00841823108357VG04A-IS00X-0KH
00841823108340VG04A-IS00X-0KG
00841823108333TS16R-SP10X-000
00841823108326TS12R-SS10X-000
00841823108319TS12R-SP10X-0E2
00841823108302TS12R-SP10X-000
00841823108296TS12R-SP05X-000
00841823108289TS12R-AP10X-0W6
00841823108272TS10R-SS10X-000
00841823108265TS10R-SP10X-000
00841823108258TS10R-AP10X-0W6
00841823108241TS08R-SS10X-000
00841823108234TS08R-SS05X-000
00841823108227TS08R-SP10X-0T8
00841823108210TS08R-SP10X-0P1
00841823108203TS08R-SP10X-0E2
00841823108197TS08R-SP10X-000
00841823108180TS08R-AP10X-0W6
00841823108173TS06R-SS10X-000
00841823108166TS06R-SP10X-0T8
00841823108159TS06R-SP10X-0T7
00841823108142TS06R-SP10X-0P1
00841823108135TS06R-SP10X-0E2
00841823108128TS06R-SP10X-000
00841823108111TS06R-IP10X-0H1
00841823108104TS06R-AS10X-0W6
00841823108098TS06R-AP10X-0WL
00841823108081TS06R-AP10X-0W6
00841823108074TS05R-SP10X-0T2
00841823108067TS04R-SS15X-000
00841823108050TS04R-SS10X-000
00841823108043TS04R-SP15X-000
00841823108036TS04R-SP10X-0T8
00841823108029TS04R-SP10X-0P1
00841823108012TS04R-SP10X-000
00841823108005TS04R-SP05X-000
00841823107992TS04R-AS10X-0W6
00841823107985TS04R-AP10X-0W6
00841823107978TS02R-SS10X-000
00841823107961TS02R-SP10X-000
00841823107954TS01R-SP00X-0W6
00841823107947TG96P-MP03X-Z00
00841823107930TG09A-MP03X-000
00841823107923TG08A-MP03X-0JF
00841823107350RS14R-SP05X-0WK
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