NeoLead RadioLucent N305

GUDID 10812594010290

Electrode (Box of 20)

NEOTECH PRODUCTS, INC.

Electrocardiographic electrode, single-use
Primary Device ID10812594010290
NIH Device Record Keyff33cdb5-1d23-4a75-b05c-a3c865cc002d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoLead RadioLucent
Version Model Number10812594010290
Catalog NumberN305
Company DUNS198013435
Company NameNEOTECH PRODUCTS, INC.
Device Count50
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812594010286 [Unit of Use]
GS110812594010290 [Primary]

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 Date2021-06-14
Device Publish Date2016-09-14

On-Brand Devices [NeoLead RadioLucent]

00812594010293812594010293
10812594010290Electrode (Box of 20)

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