Relay Plus Thoracic Stent-Graft with Plus Delivery System 28-M338100382490U

GUDID 00843576101722

Endovascular stent-graft system

Bolton Medical Inc.

Descending thoracic aorta endovascular stent-graft
Primary Device ID00843576101722
NIH Device Record Key9ca597d3-bac8-43e3-a01a-9577fa2a0444
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelay Plus Thoracic Stent-Graft with Plus Delivery System
Version Model Number28-M338100382490U
Catalog Number28-M338100382490U
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
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter
Catheter Gauge24 French
Outer Diameter38 Millimeter
Length100 Millimeter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100843576101722 [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 with Plus Delivery System]

08435761002420Endovascular stent-graft system
08435761001720Endovascular stent-graft system
00843576102422Endovascular stent-graft system
00843576101722Endovascular stent-graft system

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