RelayPro Thoracic Stent-Graft System 28-N4-26-110-34U

GUDID 00843576165946

Endovascular Stent-Graft System

Bolton Medical Inc.

Descending thoracic aorta endovascular stent-graft
Primary Device ID00843576165946
NIH Device Record Key4fcd479f-3f42-4314-be0c-e504ee428b29
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelayPro Thoracic Stent-Graft System
Version Model Number28-N4-26-110-34U
Catalog Number28-N4-26-110-34U
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
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length110 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French
Outer Diameter26 Millimeter
Outer Diameter34 Millimeter
Length107 Millimeter
Catheter Gauge21 French

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100843576165946 [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 Date2022-05-12
Device Publish Date2022-05-04

On-Brand Devices [RelayPro Thoracic Stent-Graft System]

00843576151222Endovascular Stent-Graft System
00843576151215Endovascular Stent-Graft System
00843576151192Endovascular Stent-Graft System
00843576151185Endovascular Stent-Graft System
00843576151178Endovascular Stent-Graft System
00843576151161Endovascular Stent-Graft System
00843576151154Endovascular Stent-Graft System
00843576151147Endovascular Stent-Graft System
00843576151130Endovascular Stent-Graft System
00843576151123Endovascular Stent-Graft System
00843576151116Endovascular Stent-Graft System
00843576151109Endovascular Stent-Graft System
00843576151093Endovascular Stent-Graft System
00843576151086Endovascular Stent-Graft System
00843576151079Endovascular Stent-Graft System
00843576151062Endovascular Stent-Graft System
00843576151055Endovascular Stent-Graft System
00843576151048Endovascular Stent-Graft System
00843576151031Endovascular Stent-Graft System
00843576151024Endovascular Stent-Graft System
00843576151017Endovascular Stent-Graft System
00843576151000Endovascular Stent-Graft System
00843576150997Endovascular Stent-Graft System
00843576150980Endovascular Stent-Graft System
00843576150973Endovascular Stent-Graft System
00843576150966Endovascular Stent-Graft System
00843576150959Endovascular Stent-Graft System
00843576150942Endovascular Stent-Graft System
00843576150935Endovascular Stent-Graft System
00843576150928Endovascular Stent-Graft System
00843576150911Endovascular Stent-Graft System
00843576150904Endovascular Stent-Graft System
00843576150898Endovascular Stent-Graft System
00843576150881Endovascular Stent-Graft System
00843576150867Endovascular Stent-Graft System
00843576150850Endovascular Stent-Graft System
00843576150843Endovascular Stent-Graft System
00843576150836Endovascular Stent-Graft System
00843576150829Endovascular Stent-Graft System
00843576150812Endovascular Stent-Graft System
00843576150799Endovascular Stent-Graft System
00843576150782Endovascular Stent-Graft System
00843576150775Endovascular Stent-Graft System
00843576150768Endovascular Stent-Graft System
00843576150751Endovascular Stent-Graft System
00843576150744Endovascular Stent-Graft System
00843576150737Endovascular Stent-Graft System
00843576150720Endovascular Stent-Graft System
00843576150713Endovascular Stent-Graft System
00843576150706Endovascular Stent-Graft System
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