Relay Plus Thoracic Stent-Graft with Plus Delivery System 28-M338100382490U

GUDID 00843576101722

Endovascular stent-graft system

Bolton Medical Inc.

Descending thoracic aorta endovascular stent-graft

• Primary Device ID: 00843576101722
• NIH Device Record Key: 9ca597d3-bac8-43e3-a01a-9577fa2a0444
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Relay Plus Thoracic Stent-Graft with Plus Delivery System
• Version Model Number: 28-M338100382490U
• Catalog Number: 28-M338100382490U
• 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

• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 24 French
• Outer Diameter: 38 Millimeter
• Length: 100 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843576101722 [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: 2021-02-10
• Device Publish Date: 2021-02-02

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

• 08435761002420: Endovascular stent-graft system
• 08435761001720: Endovascular stent-graft system
• 00843576102422: Endovascular stent-graft system
• 00843576101722: Endovascular stent-graft system