Disposable Sure-Flex Balloon Dilatation Catheter

GUDID 00813353010011

Esophageal Dilator 10mm Diameter x 4cm Length Balloon Dimension 200cm Total Catheter Length

Telemed Systems

Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator

• Primary Device ID: 00813353010011
• NIH Device Record Key: 1a4eec62-3a9d-4194-b97d-7655ad7a00dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Sure-Flex Balloon Dilatation Catheter
• Version Model Number: 1002
• 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	00813353010011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901424

FDA Product Code

• KNQ: Dilator, Esophageal

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 Balloon Dilatation Catheter]

• 00813353010073: Esophageal Dilator 18mm Diameter x 8cm Length Balloon Dimension 200cm Total Catheter Length
• 00813353010066: Esophageal Dilator 16mm Diameter x 8cm Length Balloon Dimension 200cm Total Catheter Length
• 00813353010059: Esophageal Dilator 16mm Diameter x 4cm Length Balloon Dimension 200cm Total Catheter Length
• 00813353010042: Esophageal Dilator 14mm Diameter x 8cm Length Balloon Dimension 200cm Total Catheter Length
• 00813353010035: Esophageal Dilator 12mm Diameter x 8cm Length Balloon Dimension 200cm Total Catheter Length
• 00813353010028: Esophageal Dilator 10mm Diameter x 8cm Length Balloon Dimension 200cm Total Catheter Length
• 00813353010011: Esophageal Dilator 10mm Diameter x 4cm Length Balloon Dimension 200cm Total Catheter Length
• 00813353010004: Esophageal Dilator 8mm Diameter x 8cm Length Balloon Dimensions 200cm Total Catheter Length