RelayPro NBS Thoracic Stent-Graft System 28-N4-22-210-26U

GUDID 00843576164123

Endovascular Stent-Graft System

Bolton Medical Inc.

Descending thoracic aorta endovascular stent-graft
Primary Device ID00843576164123
NIH Device Record Key7b960036-659d-415a-b7e8-8c599b39aa3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelayPro NBS Thoracic Stent-Graft System
Version Model Number28-N4-22-210-26U
Catalog Number28-N4-22-210-26U
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 Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 French
Outer Diameter22 Millimeter
Outer Diameter26 Millimeter
Length210 Millimeter
Catheter Gauge19 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100843576164123 [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 Date2023-05-02
Device Publish Date2023-04-24

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

00843576172111Endovascular Stent-Graft System
00843576172104Endovascular Stent-Graft System
00843576172098Endovascular Stent-Graft System
00843576172081Endovascular Stent-Graft System
00843576171220Endovascular Stent-Graft System
00843576171213Endovascular Stent-Graft System
00843576171206Endovascular Stent-Graft System
00843576171190Endovascular Stent-Graft System
00843576171183Endovascular Stent-Graft System
00843576170308Endovascular Stent-Graft System
00843576170292Endovascular Stent-Graft System
00843576170285Endovascular Stent-Graft System
00843576170278Endovascular Stent-Graft System
00843576170261Endovascular Stent-Graft System
00843576170254Endovascular Stent-Graft System
00843576169364Endovascular Stent-Graft System
00843576169357Endovascular Stent-Graft System
00843576169340Endovascular Stent-Graft System
00843576169333Endovascular Stent-Graft System
00843576169326Endovascular Stent-Graft System
00843576169319Endovascular Stent-Graft System
00843576168350Endovascular Stent-Graft System
00843576168343Endovascular Stent-Graft System
00843576168336Endovascular Stent-Graft System
00843576168329Endovascular Stent-Graft System
00843576168312Endovascular Stent-Graft System
00843576168305Endovascular Stent-Graft System
00843576168299Endovascular Stent-Graft System
00843576168282Endovascular Stent-Graft System
00843576168275Endovascular Stent-Graft System
00843576167353Endovascular Stent-Graft System
00843576167346Endovascular Stent-Graft System
00843576167339Endovascular Stent-Graft System
00843576167322Endovascular Stent-Graft System
00843576167315Endovascular Stent-Graft System
00843576167308Endovascular Stent-Graft System
00843576167292Endovascular Stent-Graft System
00843576167285Endovascular Stent-Graft System
00843576167278Endovascular Stent-Graft System
00843576166400Endovascular Stent-Graft System
00843576166394Endovascular Stent-Graft System
00843576166387Endovascular Stent-Graft System
00843576166370Endovascular Stent-Graft System
00843576166363Endovascular Stent-Graft System
00843576166356Endovascular Stent-Graft System
00843576166349Endovascular Stent-Graft System
00843576166332Endovascular Stent-Graft System
00843576166325Endovascular Stent-Graft System
00843576165519Endovascular Stent-Graft System
00843576165502Endovascular Stent-Graft System

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