Disposable Sure-Flex Biliary Balloon Dilatation Catheter

GUDID 00813353010097

Biliary Dilator 8mm Diameter x 4cm Length Balloon Dimension 180cm Total Catheter Length

Telemed Systems

Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter

• Primary Device ID: 00813353010097
• NIH Device Record Key: 0fcb0c08-0eca-40aa-b480-75c51ed611b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Sure-Flex Biliary Balloon Dilatation Catheter
• Version Model Number: 1344
• Company DUNS: 017939239
• Company Name: Telemed Systems
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813353010097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901432

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: 2023-07-20
• Device Publish Date: 2023-07-12

On-Brand Devices [Disposable Sure-Flex Biliary Balloon Dilatation Catheter]

• 00813353010103: Biliary Dilator 10mm Diameter x 8cm Length Balloon Dimension 180cm Total Catheter Length
• 00813353010097: Biliary Dilator 8mm Diameter x 4cm Length Balloon Dimension 180cm Total Catheter Length
• 00813353010080: Biliary Dilator 6mm Diameter x 2cm Length Balloon Dimension 180cm Total Catheter Length