Biliary Over the Wire Balloon Dilator 3182

GUDID M84931820

A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.

HOBBS MEDICAL, INC.

Gastrointestinal/biliary dilation balloon catheter, non-medicated

• Primary Device ID: M84931820
• NIH Device Record Key: 487c83bf-2faa-4473-91e1-9fb25cc4c2b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biliary Over the Wire Balloon Dilator
• Version Model Number: 3182
• Catalog Number: 3182
• Company DUNS: 076769355
• Company Name: HOBBS MEDICAL, INC.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M84931820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K834413

FDA Product Code

• KNQ: Dilator, Esophageal

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: 2024-12-23
• Device Publish Date: 2016-09-21

On-Brand Devices [Biliary Over the Wire Balloon Dilator]

• M84931840: A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
• M84931820: A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
• M84931800: A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically