WallFlex™ Biliary M00547440

GUDID 00191506026189

RX Partially Covered Stent System

BOSTON SCIENTIFIC CORPORATION

Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable Polymer-metal biliary stent, non-bioabsorbable

• Primary Device ID: 00191506026189
• NIH Device Record Key: 7453bfc1-a5b2-46f5-8066-8a45e49b7c3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WallFlex™ Biliary
• Version Model Number: M00547440
• Catalog Number: M00547440
• 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: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 10 Millimeter
• Stent Length: 100 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506026189 [Primary]

FDA Product Code

• FGE: Stents, drains and dilators for the biliary ducts

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: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [WallFlex™ Biliary]

• 08714729764922: WALLFLEX BILIARY RX COVERED 10X80
• 08714729764915: WALLFLEX BILIARY RX COVERED 10X60
• 08714729764908: WALLFLEX BILIARY RX COVERED 10X40
• 08714729764892: WALLFLEX BILIARY RX COVERED 8X80
• 08714729764885: WALLFLEX BILIARY RX COVERED 8X60
• 08714729759331: Stent System
• 08714729759324: Stent System
• 08714729759317: Stent System
• 08714729759300: Stent System
• 08714729759294: Stent System
• 08714729765332: Stent System
• 08714729759287: Stent System
• 08714729759270: Stent System
• 08714729759263: Stent System
• 08714729759256: Stent System
• 08714729759249: Stent System
• 08714729758150: Stent System
• 08714729756231: Stent System
• 00191506026226: RX Fully Covered Stent System
• 00191506026202: RX Fully Covered Stent System
• 00191506026189: RX Partially Covered Stent System
• 00191506026165: RX Partially Covered Stent System