NeuroNav with Autoclavable Drive Headstage NNW-006008-55

GUDID 27290114060909

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114060909
NIH Device Record Key0e116fd4-88fc-47ca-8626-f989a466f65c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroNav with Autoclavable Drive Headstage
Version Model NumberRev. 5
Catalog NumberNNW-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
GS127290114060909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

Dry Heat Sterilization


[27290114060909]

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 [NeuroNav with Autoclavable Drive Headstage]

27290016450068NeuroNav with Autoclavable Drive Headstage
27290114060909Rev. 5

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