NeoLead RadioLucent CE N305CE

GUDID 10812594011808

Electrode (Box of 20)

NEOTECH PRODUCTS, INC.

Electrocardiographic electrode, single-use
Primary Device ID10812594011808
NIH Device Record Keycaf8948f-79c0-414e-bb74-6c815cdf5cf5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoLead RadioLucent CE
Version Model Number10812594011808
Catalog NumberN305CE
Company DUNS198013435
Company NameNEOTECH PRODUCTS, INC.
Device Count20
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
GS100812594011801 [Unit of Use]
GS110812594011808 [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 Date2017-02-20

Devices Manufactured by NEOTECH PRODUCTS, INC.

00812594011405 - Little Sucker Cover2022-05-31 Protective Cover (Qty. 50)
10812594010795 - Meconium Aspirator2022-01-24
10812594010818 - Meconium Aspirator Tinted2022-01-24
10812594012584 - NeoBond Shapes (Hearts) (N7426)2022-01-24
00812594010330 - NeoBond2021-06-23 Hydrocolloid Strip
00812594011603 - NeoBond2021-06-23 Hydrocolloid Roll - 1" x 15' Roll
00812594012198 - EZCare Softouch - Pink2021-06-23 Trach Holder 6" - Pink
00812594012204 - EZCare Softouch - Pink2021-06-23 Trach Holder 7" - Pink

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