Cannula STR-000021-31

GUDID 07290014954649

ALPHA OMEGA ENGINEERING CO. LTD.

Intracerebral cannula, implantable
Primary Device ID07290014954649
NIH Device Record Keyc7b23459-5000-4030-a21a-a80f0f9742a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannula
Version Model NumberStandard
Catalog NumberSTR-000021-31
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
GS107290014954649 [Primary]
GS117290014954646 [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

On-Brand Devices [Cannula]

07290016450828insertion tube Array electrode
07290016450804Insertion Tube Set 15mm above
07290016450798Insertion Tube Set 20mm above
07290016450781Insertion Tube Set 40mm above
07290016450774Lead Insertion Tube
07290016450767Extractor
07290016450750Stylet without Cannula
07290016450743Tapered
17290016450733Tapered
07290016450729Standard Without Stylet
07290016450712Standard
07290016450705Standard
07290016450699Standard
07290016450682Standard
07290016450675Standard
07290016450668Standard
07290016450651Standard
07290016450644Standard
07290016450637Standard
17290014954905Standard
17290014954899Standard
07290014954823Array electrode insertion tube
07290014954809Insertion Tube Set 15mm above
07290014954793Insertion Tube Set 20mm above
07290014954762Extractor
07290014954755Stylet
07290014954748Tapered
07290014954731Tapered
07290014954717Standard
07290014954700Standard
07290014954694Standard
07290014954687Standard
07290014954670Standard
07290014954663Standard
07290014954656Standard
07290014954649Standard
07290014954632Standard
17290114060407Sterile Nexframe/Starfix Stainless Steel Guide Tube (cannula) and Stylet
07290114061094Standard
17290114061039Standard
07290114061025Standard
17290114061015Standard
17290114061008Standard
07290114060998Standard
07290114060981Standard
07290114060974Standard
17290014954103Sterile Nexframe/Starfix Stainless Steel Guide Tube (cannula) and Stylet

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