Tab Electrodes

GUDID 00616784712635

DYNAREX CORPORATION

Electrocardiographic electrode, single-use
Primary Device ID00616784712635
NIH Device Record Key9dc54331-729e-48fe-8680-774586d4a1b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTab Electrodes
Version Model Number7126
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
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
GS100616784712604 [Unit of Use]
GS100616784712611 [Primary]
GS100616784712628 [Package]
Contains: 00616784712611
Package: [5 Units]
In Commercial Distribution
GS100616784712635 [Package]
Contains: 00616784712628
Package: [10 Units]
In Commercial Distribution

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-11-29

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