Relay Plus Thoracic Stent-Graft System 28-M338190342590U

GUDID 00843576102316

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 ID00843576102316
NIH Device Record Key94c0745c-4fa0-41fe-b0f9-3d165119bfc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelay Plus Thoracic Stent-Graft System
Version Model Number28-M338190342590U
Catalog Number28-M338190342590U
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 Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 French
Outer Diameter34 Millimeter
Length190 Millimeter
Outer Diameter38 Millimeter
Catheter Gauge25 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100843576102316 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-10
Device Publish Date2021-02-02

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

08435761002383Endovascular stent-graft system
08435761002314Endovascular stent-graft system
00843576102385Endovascular stent-graft system
00843576102316Endovascular stent-graft system
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