LeadConfirm STR-000766-00

GUDID 07290114061070

ALPHA OMEGA ENGINEERING CO. LTD.

Electrical-only medical device connection cable, single-use
Primary Device ID07290114061070
NIH Device Record Keya5d022b9-0a6e-4425-aa0f-5b2c51237cac
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeadConfirm
Version Model NumberSterile NeuroSmart/NeuroNav MER LeadConfirm M Cabl
Catalog NumberSTR-000766-00
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290114061070 [Primary]
GS117290114061077 [Package]
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-25
Device Publish Date2021-02-17

On-Brand Devices [LeadConfirm]

17290114061084Sterile NeuroSmart/NeuroNav MER LeadConfirm M_S Ca
07290114061070Sterile NeuroSmart/NeuroNav MER LeadConfirm M Cabl
17290114061060Sterile NeuroSmart/NeuroNav LeadConfirm M_S Cable
17290114061053Sterile Neuro Omega MER LeadConfirm M_S Cable
17290114061046Sterile LeadConfirm M_S Cable
17290114060865Sterile NeuroSmart/NeuroNav LeadConfirm M Adaptor
17290114060834Sterile Neuro Omega LeadConfirm A Adaptor
17290114060476Sterile Neuro Omega LeadConfirm A Adaptor
17290114060452Sterile Neuro Omega LeadConfirm M Adaptor
17290114060445Sterile Neuro Omega LeadConfirm A Cable
17290114060421Sterile Neuro Omega LeadConfirm B Cable
07290114060417Sterile Neuro Omega LeadConfirm M Cable

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