NeuroSmart with AutoClavable Drive Headstage NSW-006008-55

GUDID 27290114060442

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114060442
NIH Device Record Keyefabbf73-07fb-44e8-a12c-85e17bddde7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroSmart with AutoClavable Drive Headstage
Version Model NumberNeuroSmart with AutoClavable Drive Headstage
Catalog NumberNSW-006008-55
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS127290114060442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290114060442]

Dry Heat Sterilization


[27290114060442]

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 with AutoClavable Drive Headstage]

27290016450099NeuroSmart with AutoClavable Drive Headstage
27290114060442NeuroSmart with AutoClavable Drive Headstage
27290114060916Rev. 5

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