Home GUDID 00860009800670 Glean
Primary DI 00860009800670
Brand Glean
Company Bright Uro, Inc
Model GUS-1000-A
Catalog number Glean-1000-A
Device description Glean Abdominal Sensor 5 Pack
Published 2026-07-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name EXQ Cystometer, Electrical Recording EXY Uroflowmeter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EXQ Cystometer, Electrical Recording Gastroenterology, Urology 2 EXY Uroflowmeter Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860009800670 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860009800670 00860009800670 860009800670 0860009800670
GMDN Terms# Term, Definition table Term Definition Anorectal manometer An electrically-powered, probe-like device intended to measure anal sphincter contraction force to facilitate assessment/diagnosis of anal incontinence and/or constipation; it may also provide bio-feedback functionality. It is inserted into the rectum and has sensors for measuring anal sphincter function during voluntary control and/or rectosphincteric reflex; data is sent wirelessly to dedicated software on a computerized device for visual display and analysis. It may have a distal sensor for measuring intra-rectal pressure, and is typically provided with accessories to enable the clinical procedure.
Regulatory Flags# DUNS number 117955543 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860009800663 Glean Bright Uro, Inc EXQ 2026-07-29 00860009800663 Glean Bright Uro, Inc EXY 2026-07-29 00890477000395 Tri-Electrode Surface EMG SRS Medical Systems, Inc. EXQ 2026-03-04 00089047700395 Tri-Electrode Surface EMG SRS Medical Systems, Inc. EXQ 2026-03-04 00890477000371 EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag) SRS Medical Systems, Inc. EXQ 2026-01-21 00890477000388 EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag) SRS Medical Systems, Inc. EXQ 2026-01-21 00086000980061 Glean Bright Uro, Inc EXY 2025-09-23 00086000980061 Glean Bright Uro, Inc EXQ 2025-09-23 00860009800601 Glean Bright Uro, Inc EXY 2025-09-23 00860009800601 Glean Bright Uro, Inc EXQ 2025-09-23 00860009800625 Glean Bright Uro, Inc EXQ 2025-09-23 00860009800632 Glean Bright Uro, Inc EXY 2025-09-23 00860009800632 Glean Bright Uro, Inc EXQ 2025-09-23 00860009800649 Glean Bright Uro, Inc EXQ 2025-09-23 00860009800649 Glean Bright Uro, Inc EXY 2025-09-23 00860009800656 Glean Bright Uro, Inc EXY 2025-09-23 00860009800656 Glean Bright Uro, Inc EXQ 2025-09-23 08032248487123 Atmos DELTA MED SPA EXQ 2025-09-02 08032248487147 Atmos DELTA MED SPA EXQ 2025-09-02 08032248487185 Infusion Set DELTA MED SPA EXQ 2025-09-02 08032248490130 Atmos DELTA MED SPA EXQ 2025-09-02 38032248487124 Atmos DELTA MED SPA EXQ 2025-09-02 08032248487130 Atmos DELTA MED SPA EXQ 2025-09-02 38032248487148 Atmos DELTA MED SPA EXQ 2025-09-02 38032248487186 Infusion Set DELTA MED SPA EXQ 2025-09-02 38032248490131 Atmos DELTA MED SPA EXQ 2025-09-02 07290019239017 FIZE kUO Console FIZE RESEARCH LTD EXY 2025-04-29 07290019239024 FIZE kUO Console FIZE RESEARCH LTD EXY 2025-04-29 07290019239031 FIZE kUO Console FIZE RESEARCH LTD EXY 2025-04-29 07290019239208 FIZE kUO Disposable Pediatric Kit FIZE RESEARCH LTD EXY 2025-04-29