NexDrive Electrode Holder 700-000316-02

GUDID 27290016450242

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290016450242
NIH Device Record Key12e7c92f-0ca8-4171-aaab-d8a72f5f8a8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexDrive Electrode Holder
Version Model NumberNexDrive Electrode Holder - Pack of 2
Catalog Number700-000316-02
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS127290016450242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290016450242]

Dry Heat Sterilization


[27290016450242]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-12
Device Publish Date2020-05-04

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