Relay Thoracic Stent-Graft with Plus Delivery System 28M346155422690U

GUDID 08426950563662

Endovascular stent-graft system

Bolton Medical Inc.

Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft
Primary Device ID08426950563662
NIH Device Record Key71e0b11e-6673-4604-8e5e-1251653d4994
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelay Thoracic Stent-Graft with Plus Delivery System
Version Model Number28M346155422690U
Catalog Number28M346155422690U
Company DUNS847424462
Company NameBolton Medical Inc.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French
Outer Diameter42 Millimeter
Outer Diameter46 Millimeter
Length155 Millimeter
Catheter Gauge26 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950563662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-12-21
Device Publish Date2014-09-22

On-Brand Devices [Relay Thoracic Stent-Graft with Plus Delivery System]

08426950563693Endovascular stent-graft system
08426950563686Endovascular stent-graft system
08426950563679Endovascular stent-graft system
08426950563662Endovascular stent-graft system
08426950563655Endovascular stent-graft system
08426950563648Endovascular stent-graft system
08426950563631Endovascular stent-graft system
08426950563624Endovascular stent-graft system
08426950563617Endovascular stent-graft system
08426950563600Endovascular stent-graft system
08426950563594Endovascular stent-graft system
08426950563587Endovascular stent-graft system
08426950563570Endovascular stent-graft system
08426950563563Endovascular stent-graft system
08426950563556Endovascular stent-graft system
08426950563549Endovascular stent-graft system
08426950563532Endovascular stent-graft system
08426950563525Endovascular stent-graft system
08426950563518Endovascular stent-graft system
08426950563501Endovascular stent-graft system
08426950563495Endovascular stent-graft system
08426950563488Endovascular stent-graft system
08426950563471Endovascular stent-graft system
08426950563464Endovascular stent-graft system
08426950563457Endovascular stent-graft system
08426950563440Endovascular stent-graft system
08426950563433Endovascular stent-graft system
08426950563426Endovascular stent-graft system
08426950563419Endovascular stent-graft system
08426950563402Endovascular stent-graft system
08426950563396Endovascular stent-graft system
08426950563389Endovascular stent-graft system
08426950563372Endovascular stent-graft system
08426950563365Endovascular stent-graft system
08426950563358Endovascular stent-graft system
08426950563341Endovascular stent-graft system
08426950563334Endovascular stent-graft system
08426950563327Endovascular stent-graft system
08426950563310Endovascular stent-graft system
08426950563303Endovascular stent-graft system
08426950563297Endovascular stent-graft system
08426950563280Endovascular stent-graft system
08426950563273Endovascular stent-graft system
08426950563266Endovascular stent-graft system
08426950563259Endovascular stent-graft system
08426950563242Endovascular stent-graft system
08426950563235Endovascular stent-graft system
08426950563228Endovascular stent-graft system
08426950563211Endovascular stent-graft system
08426950563204Endovascular stent-graft system

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