EAR ELEC3.5" DROPS E5-6S DROPS

GUDID 00811478012217

ELECTRO-CAP INTERNATIONAL INC

Analytical scalp lead
Primary Device ID00811478012217
NIH Device Record Key35b53b29-9516-4c15-8d92-07cee7f9e780
Commercial Distribution StatusIn Commercial Distribution
Brand NameEAR ELEC3.5" DROPS
Version Model NumberE5-6S DROPS
Catalog NumberE5-6S DROPS
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

Phone18005272193
Emaileci@electro-cap.com
Phone18005272193
Emaileci@electro-cap.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811478012217 [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

On-Brand Devices [EAR ELEC3.5" DROPS]

00811478012217E5-6S DROPS
00811478011838E5-9S DROPS

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