Relay Plus Thoracic Stent Graft System 28-M330250262390U

GUDID 00843576102378

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 ID00843576102378
NIH Device Record Key1035fed2-1ae1-4fa1-9baa-d3edac7f472a
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelay Plus Thoracic Stent Graft System
Version Model Number28-M330250262390U
Catalog Number28-M330250262390U
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 Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 French
Outer Diameter26 Millimeter
Length250 Millimeter
Outer Diameter30 Millimeter
Catheter Gauge23 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
GS100843576102378 [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]

08435761002376Endovascular stent-graft system
00843576102378Endovascular stent-graft system
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