Home GUDID 10809160032589 AVID TruCustom
Primary DI 10809160032589
Brand AVID TruCustom
Company AVID MEDICAL, INC.
Model ADVH093_0001
Published 2016-09-09
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name DXZ PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20809160032586 Package GS1 12 Not in Commercial Distribution 10809160032589 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20809160032586 20809160032586 10809160032589 10809160032589
GMDN Terms# Term, Definition table Term Definition Cardiovascular patch, synthetic An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair).
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 015623119 Device count 1 DM exempt true Premarket exempt true Kit true Lot or batch true Expiration date on label true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10888439624281 CARDINAL HEALTH Cardinal Health 200, LLC DXZ 2019-12-16 14026704634504 DEKNATEL TELEFLEX INCORPORATED DXZ 2019-11-21 14026704646750 DEKNATEL TELEFLEX INCORPORATED DXZ 2019-11-20 14026704646767 DEKNATEL TELEFLEX INCORPORATED DXZ 2019-11-20 14026704646781 DEKNATEL TELEFLEX INCORPORATED DXZ 2019-11-20 14026704646798 DEKNATEL TELEFLEX INCORPORATED DXZ 2019-11-20 14026704646804 DEKNATEL TELEFLEX INCORPORATED DXZ 2019-11-20 10705031462212 ETHIBOND EXCEL ETHICON, LLC DXZ 2019-07-04 10705031462229 ETHIBOND EXCEL ETHICON, LLC DXZ 2019-07-04 10705031462281 ETHIBOND EXCEL ETHICON, LLC DXZ 2019-07-04 10705031462304 ETHIBOND EXCEL ETHICON, LLC DXZ 2019-07-04 10705031462335 ETHIBOND EXCEL ETHICON, LLC DXZ 2019-07-04 10705031462359 ETHIBOND EXCEL ETHICON, LLC DXZ 2019-07-04 10705031462366 ETHIBOND EXCEL ETHICON, LLC DXZ 2019-07-04 10705031462373 ETHIBOND EXCEL ETHICON, LLC DXZ 2019-07-04 10705031462403 ETHIBOND EXCEL ETHICON, LLC DXZ 2019-07-04 00859389005102 Tyke, Patch, Pledget and Intracardiac Elutia Med LLC DXZ 2019-02-28 14026704638540 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-12-03 14026704638557 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-12-03 14026704638564 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-12-03 14026704638571 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-12-03 14026704638588 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-12-03 14026704638601 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-12-03 14026704638618 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-12-03 14026704638625 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-12-03 14026704638632 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-12-03 14026704638649 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-12-03 14026704638656 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-12-03 14026704638663 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-12-03 14026704634818 DEKNATEL TELEFLEX INCORPORATED DXZ 2018-07-30