HAART 200-19US

GUDID 10857160006239

Aortic Annuloplasty Ring

BIOSTABLE ENGINEERING & SCIENCE

Aortic annuloplasty ring
Primary Device ID10857160006239
NIH Device Record Key2f2ea065-224b-4925-b723-88243f9f7196
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAART
Version Model Number200-19US
Catalog Number200-19US
Company DUNS012321281
Company NameBIOSTABLE ENGINEERING & SCIENCE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com
Phone512-970-9112
Emailjulie.thomas@biostable-s-e.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110857160006239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PSTAortic Annuloplasty Ring

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-05
Device Publish Date2017-09-27

On-Brand Devices [HAART]

10857160006307Aortic Annuloplasty Ring
10857160006291Aortic Annuloplasty Ring
10857160006284Aortic Annuloplasty Device
10857160006277Aortic Annuloplasty Ring
10857160006260Aortic Annuloplasty Device
10857160006253Aortic Annuloplasty Device
10857160006246Aortic Annuloplasty Device
10857160006239Aortic Annuloplasty Ring

Trademark Results [HAART]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAART
HAART
78172481 2819695 Dead/Cancelled
Haart Limited
2002-10-09
HAART
HAART
77679691 4257921 Live/Registered
BioStable Science & Engineering, Inc.
2009-02-27

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