WallFlex™ Duodenal

GUDID 08714729902492

Stent System with Anchor Lock Delivery System

BOSTON SCIENTIFIC CORPORATION

Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent Bare-metal duodenal stent

• Primary Device ID: 08714729902492
• NIH Device Record Key: e3e2919f-ef82-4ca1-a784-d77fd4d91290
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WallFlex™ Duodenal
• Version Model Number: M00555860
• 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: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729902492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200257

FDA Product Code

• MUM: Stent, metallic, expandable, duodenal

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: 2020-06-03
• Device Publish Date: 2020-05-26

On-Brand Devices [WallFlex™ Duodenal]

• 08714729902515: Stent System with Anchor Lock Delivery System
• 08714729902508: Stent System with Anchor Lock Delivery System
• 08714729902492: Stent System with Anchor Lock Delivery System