Relay Thoracic Stent-Graft with Plus Delivery System 28M346155422690U

GUDID 08426950563662

Endovascular stent-graft system

Bolton Medical Inc.

Descending thoracic aorta endovascular stent-graft

• Primary Device ID: 08426950563662
• NIH Device Record Key: 71e0b11e-6673-4604-8e5e-1251653d4994
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Relay Thoracic Stent-Graft with Plus Delivery System
• Version Model Number: 28M346155422690U
• Catalog Number: 28M346155422690U
• 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: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French
• Outer Diameter: 42 Millimeter
• Outer Diameter: 46 Millimeter
• Length: 155 Millimeter
• Catheter Gauge: 26 French

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950563662 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-12-21
• Device Publish Date: 2014-09-22

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

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• 08426950563440: Endovascular stent-graft system
• 08426950563433: Endovascular stent-graft system
• 08426950563426: Endovascular stent-graft system
• 08426950563419: Endovascular stent-graft system
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• 08426950563358: Endovascular stent-graft system
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• 08426950563334: Endovascular stent-graft system
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• 08426950563303: Endovascular stent-graft system
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• 08426950563266: Endovascular stent-graft system
• 08426950563259: Endovascular stent-graft system
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• 08426950563235: Endovascular stent-graft system
• 08426950563228: Endovascular stent-graft system
• 08426950563211: Endovascular stent-graft system
• 08426950563204: Endovascular stent-graft system