Relay PlusThoracic Stent-Graft System 28-M338145382490U

GUDID 08435761001850

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 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 ID08435761001850
NIH Device Record Keyaece66e0-8f3f-4183-8146-673a06514f5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelay PlusThoracic Stent-Graft System
Version Model Number28-M338145382490U
Catalog Number28-M338145382490U
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

Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length145 Millimeter
Catheter Gauge24 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
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
GS108435761001850 [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 Date2019-06-21
Device Publish Date2019-06-13

On-Brand Devices [Relay PlusThoracic Stent-Graft System]

08435761001850Endovascular stent-graft system
08435761001751Endovascular stent-graft system
00843576101852Endovascular stent-graft system
00843576101753Endovascular stent-graft system
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