Relay Plus Thoracic Stent-Graft System 28-M332250282490U

GUDID 08435761002383

Endovascular stent-graft system

Bolton Medical Inc.

Descending thoracic aorta endovascular stent-graft

Primary Device ID	08435761002383
NIH Device Record Key	42e44cb2-e789-4ca2-87e0-b56d55b81216
Commercial Distribution Status	In Commercial Distribution
Brand Name	Relay Plus Thoracic Stent-Graft System
Version Model Number	28-M332250282490U
Catalog Number	28-M332250282490U
Company DUNS	847424462
Company Name	Bolton Medical Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter
Catheter Gauge	24 French
Outer Diameter	32 Millimeter
Length	250 Millimeter
Outer Diameter	28 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435761002383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P110038

FDA Product Code

MIH	System, Endovascular Graft, Aortic Aneurysm Treatment

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-06-21
Device Publish Date	2019-06-13

On-Brand Devices [Relay Plus Thoracic Stent-Graft System]

08435761002383	Endovascular stent-graft system
08435761002314	Endovascular stent-graft system
00843576102385	Endovascular stent-graft system
00843576102316	Endovascular stent-graft system