DISK ELEC - 9 MM - 3 1/2" DROPS E21-9S DROP

GUDID 00811478012279

ELECTRO-CAP INTERNATIONAL INC

Analytical scalp lead Analytical scalp lead
Primary Device ID00811478012279
NIH Device Record Keybfa07e56-aead-4950-8685-83bfcd5d2bd4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDISK ELEC - 9 MM - 3 1/2" DROPS
Version Model NumberE21-9S DROP
Catalog NumberE21-9S DROP
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
GS100811478012279 [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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