TREO Abdominal Stent-Graft System 28-B2-36-100U

GUDID 08435761052470

Endovascular Stent-Graft System

Bolton Medical Inc.

Abdominal aorta endovascular stent-graft

• Primary Device ID: 08435761052470
• NIH Device Record Key: 7213d14e-7cf7-4a22-8ed5-d17ca8dad461
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TREO Abdominal Stent-Graft System
• Version Model Number: 28-B2-36-100U
• Catalog Number: 28-B2-36-100U
• 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: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 French
• Outer Diameter: 36 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 100 Millimeter
• Catheter Gauge: 19 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
• 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
• 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	08435761052470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190015

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: 2
• Public Version Date: 2020-12-21
• Device Publish Date: 2020-05-19

On-Brand Devices [TREO Abdominal Stent-Graft System ]

• 08435761052791: Endovascular Stent-Graft System
• 08435761052784: Endovascular Stent-Graft System
• 08435761052777: Endovascular Stent-Graft System
• 08435761052760: Endovascular Stent-Graft System
• 08435761052753: Endovascular Stent-Graft System
• 08435761052746: Endovascular Stent-Graft System
• 08435761052739: Endovascular Stent-Graft System
• 08435761052722: Endovascular Stent-Graft System
• 08435761052715: Endovascular Stent-Graft System
• 08435761052708: Endovascular Stent-Graft System
• 08435761052692: Endovascular Stent-Graft System
• 08435761052685: Endovascular Stent-Graft System
• 08435761052678: Endovascular Stent-Graft System
• 08435761052661: Endovascular Stent-Graft System
• 08435761052654: Endovascular Stent-Graft System
• 08435761052647: Endovascular Stent-Graft System
• 08435761052630: Endovascular Stent-Graft System
• 08435761052623: Endovascular Stent-Graft System
• 08435761052616: Endovascular Stent-Graft System
• 08435761052609: Endovascular Stent-Graft System
• 08435761052593: Endovascular Stent-Graft System
• 08435761052586: Endovascular Stent-Graft System
• 08435761052579: Endovascular Stent-Graft System
• 08435761052562: Endovascular Stent-Graft System
• 08435761052555: Endovascular Stent-Graft System
• 08435761052548: Endovascular Stent-Graft System
• 08435761052531: Endovascular Stent-Graft System
• 08435761052524: Endovascular Stent-Graft System
• 08435761052517: Endovascular Stent-Graft System
• 08435761052500: Endovascular Stent-Graft System
• 08435761052494: Endovascular Stent-Graft System
• 08435761052487: Endovascular Stent-Graft System
• 08435761052470: Endovascular Stent-Graft System
• 08435761052463: Endovascular Stent-Graft System
• 08435761052456: Endovascular Stent-Graft System
• 08435761052449: Endovascular Stent-Graft System
• 08435761052432: Endovascular Stent-Graft System
• 08435761052425: Endovascular Stent-Graft System
• 08435761052418: Endovascular Stent-Graft System
• 08435761052401: Endovascular Stent-Graft System
• 08435761052395: Endovascular Stent-Graft System
• 08435761052388: Endovascular Stent-Graft System
• 08435761052371: Endovascular Stent-Graft System
• 08435761052364: Endovascular Stent-Graft System
• 08435761052357: Endovascular Stent-Graft System
• 08435761052340: Endovascular Stent-Graft System
• 08435761052333: Endovascular Stent-Graft System
• 08435761052326: Endovascular Stent-Graft System
• 08435761052319: Endovascular Stent-Graft System
• 08435761052302: Endovascular Stent-Graft System