Axios™ M00553690

GUDID 00191506008093

Stent and Electrocautery - Enhanced Delivery System

BOSTON SCIENTIFIC CORPORATION

Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube Implantable transenteric drainage tube

• Primary Device ID: 00191506008093
• NIH Device Record Key: 8a961108-37a3-4ddf-8d73-61d86ec03bc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axios™
• Version Model Number: M00553690
• Catalog Number: M00553690
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: false
• 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

• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506008093 [Primary]

FDA Product Code

• PCU: Pancreatic stent, covered, metallic, removable

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: 2021-06-04
• Device Publish Date: 2021-05-27

On-Brand Devices [Axios™]

• 08714729904632: Stent and Delivery System
• 08714729904625: Stent and Delivery System
• 08714729951179: Stent and Electrocautery - Enhanced Delivery System
• 08714729904595: Stent and Electrocautery - Enhanced Delivery System
• 08714729904588: Stent and Electrocautery - Enhanced Delivery System
• 00191506008093: Stent and Electrocautery - Enhanced Delivery System
• 00191506008086: Stent and Electrocautery - Enhanced Delivery System