NeuroSmart MER Headstage KIT 700-026009-00

GUDID 27290114063146

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114063146
NIH Device Record Keya8f3e716-b8d9-49eb-9a6b-ca4222fc91e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroSmart MER Headstage KIT
Version Model NumberNeuroSmart MER Headstage KIT
Catalog Number700-026009-00
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exemptfalse
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
GS127290114063146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


[27290114063146]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-26
Device Publish Date2023-06-16

On-Brand Devices [NeuroSmart MER Headstage KIT]

27290016450150NeuroSmart MER HeadStage Kit
27290114060589NeuroSmart MER HeadStage KIT
27290114063146NeuroSmart MER Headstage KIT

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