Relay PlusThoracic Stent-Graft System 28-M344105442590U

GUDID 08435761001751

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 ID08435761001751
NIH Device Record Keyacd49fd3-c685-42c9-8480-f3bc27b10a1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelay PlusThoracic Stent-Graft System
Version Model Number28-M344105442590U
Catalog Number28-M344105442590U
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 Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 Millimeter
Catheter Gauge25 French
Outer Diameter44 Millimeter
Length105 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
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
GS108435761001751 [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
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00843576101753Endovascular stent-graft system
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