Relay Thoracic Stent-Graft with Plus Delivery System 28M322090222290U

GUDID 08426950562856

Endovascular stent-graft system

Bolton Medical Inc.

Descending thoracic aorta endovascular stent-graft
Primary Device ID08426950562856
NIH Device Record Keyf2e935a7-cc98-4043-8759-14a10b0a3b4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelay Thoracic Stent-Graft with Plus Delivery System
Version Model Number28M322090222290U
Catalog Number28M322090222290U
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 Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 French
Outer Diameter22 Millimeter
Length90 Millimeter
Catheter Gauge22 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
GS108426950562856 [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]

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08426950563402Endovascular stent-graft system
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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

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