Cannula STR-015521-00

GUDID 07290014954724

ALPHA OMEGA ENGINEERING CO. LTD.

Intracerebral cannula, implantable
Primary Device ID07290014954724
NIH Device Record Keyab87f884-6732-497e-93b9-69ab4e1b66ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannula
Version Model NumberStandard Without Styler
Catalog NumberSTR-015521-00
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

Customer Support Contacts

Phone8779196288
Emailm.andrea@alphaomega-eng.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290014954724 [Primary]
GS117290014954721 [Package]
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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-22
Device Publish Date2016-09-24

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