Relay Plus Thoracic Stent-Graft System 28-M346155422690U

GUDID 08435761002253

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
Primary Device ID08435761002253
NIH Device Record Key99b7678a-d08a-4da1-aa18-01ead11ffbb1
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelay Plus Thoracic Stent-Graft System
Version Model Number28-M346155422690U
Catalog Number28-M346155422690U
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 Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 Millimeter
Catheter Gauge26 French
Length155 Millimeter
Outer Diameter46 Millimeter
Outer Diameter42 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
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
GS108435761002253 [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 Plus Thoracic Stent-Graft System]

08435761002451Endovascular stent-graft system
08435761002444Endovascular stent-graft system
08435761002437Endovascular stent-graft system
08435761002413Endovascular stent-graft system
08435761002406Endovascular stent-graft system
08435761002390Endovascular stent-graft system
08435761002369Endovascular stent-graft system
08435761002352Endovascular stent-graft system
08435761002345Endovascular stent-graft system
08435761002338Endovascular stent-graft system
08435761002321Endovascular stent-graft system
08435761002307Endovascular stent-graft system
08435761002291Endovascular stent-graft system
08435761002284Endovascular stent-graft system
08435761002277Endovascular stent-graft system
08435761002260Endovascular stent-graft system
08435761002253Endovascular stent-graft system
08435761002239Endovascular stent-graft system
08435761002222Endovascular stent-graft system
08435761002215Endovascular stent-graft system
08435761002208Endovascular stent-graft system
08435761002192Endovascular stent-graft system
08435761002185Endovascular stent-graft system
08435761002178Endovascular stent-graft system
08435761002161Endovascular stent-graft system
08435761002147Endovascular stent-graft system
08435761002130Endovascular stent-graft system
08435761002123Endovascular stent-graft system
08435761002116Endovascular stent-graft system
08435761002109Endovascular stent-graft system
08435761002093Endovascular stent-graft system
08435761002086Endovascular stent-graft system
08435761002079Endovascular stent-graft system
08435761002062Endovascular stent-graft system
08435761002055Endovascular stent-graft system
08435761002048Endovascular stent-graft system
08435761002031Endovascular stent-graft system
08435761002024Endovascular stent-graft system
08435761002017Endovascular stent-graft system
08435761002000Endovascular stent-graft system
08435761001997Endovascular stent-graft system
08435761001980Endovascular stent-graft system
08435761001966Endovascular stent-graft system
08435761001959Endovascular stent-graft system
08435761001942Endovascular stent-graft system
08435761001935Endovascular stent-graft system
08435761001928Endovascular stent-graft system
08435761001911Endovascular stent-graft system
08435761001881Endovascular stent-graft system
08435761001867Endovascular stent-graft system

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