NeuroSmart Autoclavable Drive Headstage KIT 700-026008-00

GUDID 27290114060596

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114060596
NIH Device Record Key721d8cc1-78fd-4243-b1bb-1b39ece90e64
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroSmart Autoclavable Drive Headstage KIT
Version Model NumberNeuroSmart Autoclavable Drive Headstage KIT
Catalog Number700-026008-00
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS127290114060596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290114060596]

Dry Heat Sterilization


[27290114060596]

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

On-Brand Devices [NeuroSmart Autoclavable Drive Headstage KIT]

27290016450228NeuroSmart Autoclavable Drive Headstage Kit
27290114060596NeuroSmart Autoclavable Drive Headstage KIT
27290114060930Rev. 5

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