WallFlex Biliary

GUDID 08714729953197

Stent System RMV

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

• Primary Device ID: 08714729953197
• NIH Device Record Key: b27121f8-be48-444a-bab1-d05373b167a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WallFlex Biliary
• Version Model Number: M00570380
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729953197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150040

FDA Product Code

• PNB: Biliary stent system for benign strictures

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-22
• Device Publish Date: 2016-08-15

On-Brand Devices [WallFlex Biliary]

• 08714729953197: Stent System RMV
• 08714729953180: Stent System RMV
• 08714729953173: Stent System RMV
• 08714729953166: Stent System RMV
• 08714729953159: Stent System RMV