FlexiMarc G/T™

GUDID 00853730006091

Implanted Marker in Needle

CORTEX MANUFACTURING INC.

Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle
Primary Device ID00853730006091
NIH Device Record Key7532d7c5-831b-4a52-8650-56acf6e4ea58
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexiMarc G/T™
Version Model NumberFM-1.0-2-10-GT-18-20
Company DUNS832596816
Company NameCORTEX MANUFACTURING INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853730006091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEUMarker, Radiographic, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-24

On-Brand Devices [FlexiMarc G/T™]

00853730006121Implanted Marker in Needle
00853730006114Implanted Marker in Needle
00853730006107Implanted Marker in Needle
00853730006091Implanted Marker in Needle

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.