Disposable Sure-Flex Balloon Dilatation Catheter

GUDID 00813353010028

Esophageal Dilator 10mm Diameter x 8cm Length Balloon Dimension 200cm Total Catheter Length

Telemed Systems

Endoscopic gastrointestinal stenosis dilator

• Primary Device ID: 00813353010028
• NIH Device Record Key: 71c3a00c-51ae-4a0a-9cf8-1584782def62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Sure-Flex Balloon Dilatation Catheter
• Version Model Number: 1004
• 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	00813353010028 [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