BB 8 Sinus Dilation Kit

GUDID 00860013723903

excelENT, Inc.

Nasal/paranasal balloon catheter

• Primary Device ID: 00860013723903
• NIH Device Record Key: 5b5b9843-86ad-43db-8fa0-ee7612307b0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BB 8 Sinus Dilation Kit
• Version Model Number: EXM-01-020-125
• Company DUNS: 119131051
• Company Name: excelENT, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013723903 [Primary]

FDA Product Code

• LRC: Instrument, Ent Manual Surgical

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: 2025-06-19
• Device Publish Date: 2025-06-11

Devices Manufactured by excelENT, Inc.

• 00860013723903 - BB 8 Sinus Dilation Kit: 2025-06-19
• 00860013723903 - BB 8 Sinus Dilation Kit: 2025-06-19
• 00860008118707 - BB8 Sinus Dilation Kit: 2023-11-14