NeuroSmart with AutoClavable Drive Headstage NSW-006008-55

GUDID 27290114060916

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114060916
NIH Device Record Keyc7d088f0-4503-4a9b-bf00-8cb5911b1e0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroSmart with AutoClavable Drive Headstage
Version Model NumberRev. 5
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 Kittrue
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
GS127290114060916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


[27290114060916]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-15
Device Publish Date2021-02-05

On-Brand Devices [NeuroSmart with AutoClavable Drive Headstage]

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

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