ECG Snap Electrodes

GUDID 00616784710235

DYNAREX CORPORATION

Electrocardiographic electrode, single-use
Primary Device ID00616784710235
NIH Device Record Key8a1717ab-49f1-4d9a-9280-47ddb2b09306
Commercial Distribution StatusIn Commercial Distribution
Brand NameECG Snap Electrodes
Version Model Number7102
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count4
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 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
GS100616784710211 [Unit of Use]
GS100616784710228 [Primary]
GS100616784710235 [Package]
Contains: 00616784710228
Package: [150 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRXElectrode, Electrocardiograph

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 Date2016-09-24

On-Brand Devices [ECG Snap Electrodes]

006167847103347103
006167847102357102
006167847101367101

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