Electrically Conductive Gel (ECG)

GUDID 00616784123912

Electrically Conductive Gel (ECG), Conductive, Noncorrosive , Salt & Alcohol Free, Water Soluble

DYNAREX CORPORATION

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Primary Device ID00616784123912
NIH Device Record Key0e8d47d2-b7e8-470a-8f30-e5eeff5fc71e
Commercial Distribution StatusIn Commercial Distribution
Brand NameElectrically Conductive Gel (ECG)
Version Model Number1239
Company DUNS008124539
Company NameDYNAREX 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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784123912 [Primary]
GS100616784123936 [Package]
Package: [72 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GYBMedia, Electroconductive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-17
Device Publish Date2021-02-09

On-Brand Devices [Electrically Conductive Gel (ECG)]

00616784123912Electrically Conductive Gel (ECG), Conductive, Noncorrosive , Salt & Alcohol Free, Water Soluble
00616784124018Electrically Conductive Gel (ECG), Conductive, Noncorrosive, Salt & Alcohol Free, Water Soluble

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