RelayPro Thoracic Stent-Graft System 28-M4-44-105-44U

GUDID 00843576149700

Endovascular Stent-Graft System

Bolton Medical Inc.

Descending thoracic aorta endovascular stent-graft

• Primary Device ID: 00843576149700
• NIH Device Record Key: d50bc292-fa8b-4354-b9e6-dc2030b457da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RelayPro Thoracic Stent-Graft System
• Version Model Number: 28-M4-44-105-44U
• Catalog Number: 28-M4-44-105-44U
• 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: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 44 Millimeter
• Balloon Catheter Tip Length: 105 Millimeter
• Catheter Gauge: 22 French

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843576149700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200045

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: 2021-09-30
• Device Publish Date: 2021-09-22

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

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