RelayPro NBS Thoracic Stent-Graft System 28-N4-22-110-22U

GUDID 00843576163928

Endovascular Stent-Graft System

Bolton Medical Inc.

Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft Descending thoracic aorta endovascular stent-graft

• Primary Device ID: 00843576163928
• NIH Device Record Key: 3edb81a8-d049-4acf-a3d9-d220c04ce680
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RelayPro NBS Thoracic Stent-Graft System
• Version Model Number: 28-N4-22-110-22U
• Catalog Number: 28-N4-22-110-22U
• 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: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 22 Millimeter
• Length: 120 Millimeter
• Catheter Gauge: 19 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843576163928 [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: 2023-05-02
• Device Publish Date: 2023-04-24

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

• 00843576172111: Endovascular Stent-Graft System
• 00843576172104: Endovascular Stent-Graft System
• 00843576172098: Endovascular Stent-Graft System
• 00843576172081: Endovascular Stent-Graft System
• 00843576171220: Endovascular Stent-Graft System
• 00843576171213: Endovascular Stent-Graft System
• 00843576171206: Endovascular Stent-Graft System
• 00843576171190: Endovascular Stent-Graft System
• 00843576171183: Endovascular Stent-Graft System
• 00843576170308: Endovascular Stent-Graft System
• 00843576170292: Endovascular Stent-Graft System
• 00843576170285: Endovascular Stent-Graft System
• 00843576170278: Endovascular Stent-Graft System
• 00843576170261: Endovascular Stent-Graft System
• 00843576170254: Endovascular Stent-Graft System
• 00843576169364: Endovascular Stent-Graft System
• 00843576169357: Endovascular Stent-Graft System
• 00843576169340: Endovascular Stent-Graft System
• 00843576169333: Endovascular Stent-Graft System
• 00843576169326: Endovascular Stent-Graft System
• 00843576169319: Endovascular Stent-Graft System
• 00843576168350: Endovascular Stent-Graft System
• 00843576168343: Endovascular Stent-Graft System
• 00843576168336: Endovascular Stent-Graft System
• 00843576168329: Endovascular Stent-Graft System
• 00843576168312: Endovascular Stent-Graft System
• 00843576168305: Endovascular Stent-Graft System
• 00843576168299: Endovascular Stent-Graft System
• 00843576168282: Endovascular Stent-Graft System
• 00843576168275: Endovascular Stent-Graft System
• 00843576167353: Endovascular Stent-Graft System
• 00843576167346: Endovascular Stent-Graft System
• 00843576167339: Endovascular Stent-Graft System
• 00843576167322: Endovascular Stent-Graft System
• 00843576167315: Endovascular Stent-Graft System
• 00843576167308: Endovascular Stent-Graft System
• 00843576167292: Endovascular Stent-Graft System
• 00843576167285: Endovascular Stent-Graft System
• 00843576167278: Endovascular Stent-Graft System
• 00843576166400: Endovascular Stent-Graft System
• 00843576166394: Endovascular Stent-Graft System
• 00843576166387: Endovascular Stent-Graft System
• 00843576166370: Endovascular Stent-Graft System
• 00843576166363: Endovascular Stent-Graft System
• 00843576166356: Endovascular Stent-Graft System
• 00843576166349: Endovascular Stent-Graft System
• 00843576166332: Endovascular Stent-Graft System
• 00843576166325: Endovascular Stent-Graft System
• 00843576165519: Endovascular Stent-Graft System
• 00843576165502: Endovascular Stent-Graft System