Good Bi-Brush 4660

GUDID M84946603

A device used to remove dirt or debris from the working channel(s) of the endoscope prior to disinfection and sterilization. It consists of a flexible insertion tube with plastic bristles. This is a single-use device.

HOBBS MEDICAL, INC.

Surgical instrument/endoscope cleaning brush/tool, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use

• Primary Device ID: M84946603
• NIH Device Record Key: b62a838f-172a-4f85-ab24-637ec04f55cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Good Bi-Brush
• Version Model Number: 4660
• Catalog Number: 4660
• Company DUNS: 076769355
• Company Name: HOBBS MEDICAL, INC.
• Device Count: 25
• 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
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M84946600 [Unit of Use]
HIBCC	M84946603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933354

FDA Product Code

• FEB: Accessories, Cleaning, For Endoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-21

On-Brand Devices [Good Bi-Brush]

• M84946653: A device used to remove dirt or debris from the working channel(s) of the endoscope prior to dis
• M84946603: A device used to remove dirt or debris from the working channel(s) of the endoscope prior to dis