Relay Plus Thoracic Stent-Graft System 28-M332095322290U

GUDID 00843576101692

Endovascular stent-graft system

Bolton Medical Inc.

Descending thoracic aorta endovascular stent-graft

• Primary Device ID: 00843576101692
• NIH Device Record Key: ecd6eede-6da7-4344-bba6-e7bb892d0d13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Relay Plus Thoracic Stent-Graft System
• Version Model Number: 28-M332095322290U
• Catalog Number: 28-M332095322290U
• 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: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 Millimeter
• Catheter Gauge: 22 French
• Outer Diameter: 32 Millimeter
• Length: 95 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843576101692 [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 System]

• 08435761002451: Endovascular stent-graft system
• 08435761002444: Endovascular stent-graft system
• 08435761002437: Endovascular stent-graft system
• 08435761002413: Endovascular stent-graft system
• 08435761002406: Endovascular stent-graft system
• 08435761002390: Endovascular stent-graft system
• 08435761002369: Endovascular stent-graft system
• 08435761002352: Endovascular stent-graft system
• 08435761002345: Endovascular stent-graft system
• 08435761002338: Endovascular stent-graft system
• 08435761002321: Endovascular stent-graft system
• 08435761002307: Endovascular stent-graft system
• 08435761002291: Endovascular stent-graft system
• 08435761002284: Endovascular stent-graft system
• 08435761002277: Endovascular stent-graft system
• 08435761002260: Endovascular stent-graft system
• 08435761002253: Endovascular stent-graft system
• 08435761002239: Endovascular stent-graft system
• 08435761002222: Endovascular stent-graft system
• 08435761002215: Endovascular stent-graft system
• 08435761002208: Endovascular stent-graft system
• 08435761002192: Endovascular stent-graft system
• 08435761002185: Endovascular stent-graft system
• 08435761002178: Endovascular stent-graft system
• 08435761002161: Endovascular stent-graft system
• 08435761002147: Endovascular stent-graft system
• 08435761002130: Endovascular stent-graft system
• 08435761002123: Endovascular stent-graft system
• 08435761002116: Endovascular stent-graft system
• 08435761002109: Endovascular stent-graft system
• 08435761002093: Endovascular stent-graft system
• 08435761002086: Endovascular stent-graft system
• 08435761002079: Endovascular stent-graft system
• 08435761002062: Endovascular stent-graft system
• 08435761002055: Endovascular stent-graft system
• 08435761002048: Endovascular stent-graft system
• 08435761002031: Endovascular stent-graft system
• 08435761002024: Endovascular stent-graft system
• 08435761002017: Endovascular stent-graft system
• 08435761002000: Endovascular stent-graft system
• 08435761001997: Endovascular stent-graft system
• 08435761001980: Endovascular stent-graft system
• 08435761001966: Endovascular stent-graft system
• 08435761001959: Endovascular stent-graft system
• 08435761001942: Endovascular stent-graft system
• 08435761001935: Endovascular stent-graft system
• 08435761001928: Endovascular stent-graft system
• 08435761001911: Endovascular stent-graft system
• 08435761001881: Endovascular stent-graft system
• 08435761001867: Endovascular stent-graft system