Glean

Basic Information

• Brand Name: Glean
• Primary DI: 00860009800601
• Version / Model: GUS-1000-M
• Catalog Number: GUS-1000-M
• Company Name: Bright Uro, Inc
• Labeler DUNS: 117955543
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-23
• Public Version: 1
• Public Version Date: 2025-10-01
• Public Version Status: New
• Public Device Record Key: 707a1743-d8b1-4cd6-b3b5-410974a5165b

Device Description

Glean Sensor with Male Insertion Tool 5 Pack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXQ	Cystometer, Electrical Recording	Gastroenterology, Urology	876.1620	2
EXY	Uroflowmeter	Gastroenterology, Urology	876.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62243	Urodynamic manometric catheter, electronic, single-use	A sterile flexible tube with electronic pressure sensors at the distal end intended to be inserted into the bladder via the urethra for measuring urethral/bladder pressure. Also known as a urodynamic solid-state sensor catheter, it is intended for proximal connection to appropriate equipment for urodynamic examination of a patient, and may have a lumen to fill/drain the bladder to facilitate pressure measurement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009800601	GS1