ELECTRO-CAP-EX SMALL E1-XSM

GUDID 00811478011401

ELECTRO-CAP INTERNATIONAL INC

Analytical scalp lead
Primary Device ID00811478011401
NIH Device Record Keycbc99e09-3f36-4622-817e-3488b2313709
Commercial Distribution StatusIn Commercial Distribution
Brand NameELECTRO-CAP-EX SMALL
Version Model NumberE1-XSM
Catalog NumberE1-XSM
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

Phone8005272193
Emaileci@electro-cap.com
Phone8005272193
Emaileci@electro-cap.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811478011401 [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

00811478010213 - NEEDLE/SYRINGE KIT - LARGE2020-12-16
00811478011883 - ELECTRO-GEL 16oz2018-10-22
00811478011890 - ELECTRO-GEL 32oz2018-10-22
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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