Sterile neuroprobe STR-009080-00

GUDID 17290114061923

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID17290114061923
NIH Device Record Keybdc9af10-7326-4827-9935-9d2ad1c59cbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile neuroprobe
Version Model NumberShielded
Catalog NumberSTR-009080-00
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290114061926 [Primary]
GS117290114061923 [Package]
Contains: 07290114061926
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-05
Device Publish Date2023-05-26

On-Brand Devices [Sterile neuroprobe ]

17290114061770Shielded
17290114062319Shielded
17290114062258Non-Shielded
17290114062241Shielded
17290114062234Shielded
17290114062029Non-Shielded
17290114062012Non-Shielded
17290114062005Non-Shielded
17290114061992Non-Shielded
17290114061985Shielded
17290114061978Shielded
17290114061961Shielded
17290114061954Shielded
17290114061947Shielded
17290114061930Shielded
17290114061923Shielded
17290114061916Non-Shielded
17290114061909Non-Shielded
17290114061886Non-Shielded
17290114061879Non-Shielded
17290114061862Non-Shielded
17290114061855Shielded
17290114061848Non-Shielded
17290114061831Non-Shielded
17290114061824Non-Shielded
17290114061800Shielded
17290114061794Shielded
17290114061787Shielded
17290114061534Non-Shielded

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