SURGICAL CAP W/EAR DROPS - L/MED CS2005-L/M

GUDID 00811478010169

ELECTRO-CAP INTERNATIONAL INC

Analytical scalp lead Analytical scalp lead
Primary Device ID00811478010169
NIH Device Record Key90219390-6d54-47b6-98a2-1e2ec8531876
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGICAL CAP W/EAR DROPS - L/MED
Version Model NumberCS2005-L/M
Catalog NumberCS2005-L/M
Company DUNS186765806
Company NameELECTRO-CAP INTERNATIONAL INC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800 527 2193
Emaileci@electro-cap.com
Phone800 527 2193
Emaileci@electro-cap.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811478010169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by ELECTRO-CAP INTERNATIONAL INC

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00811478011883 - ELECTRO-GEL 16oz2018-10-22
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00811478011906 - ELECTRO-GEL 128OZ2018-10-22
00811478011913 - ELECTRO-GEL 16OZ. BOXED2018-10-22
00811478011920 - ELECTRO-GEL 32 OZ. BOXED2018-10-22
00811478010008 - CAP W/AG/AGCL ELECTRODES2018-07-06
00811478010015 - SPECIAL CAP2018-07-06

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