Home GUDID 10850033976264
HERizon Disposable Electronic Hysteroscope
Primary DI 10850033976264
Brand HERizon Disposable Electronic Hysteroscope
Company Minerva Surgical, Inc.
Model JY-DEH-001
Catalog number JY-DEH-001
Device description Disposable Electronic Hysteroscope For Use with HERizon Medical Endoscope Image Processor
Published 2024-10-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name HIH Hysteroscope (And Accessories)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HIH Hysteroscope (And Accessories) Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850033976264 Package GS1 10 In Commercial Distribution 00850033976267 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 10850033976264 10850033976264 00850033976267 00850033976267 850033976267 0850033976267
GMDN Terms# Term, Definition table Term Definition Rigid video hysteroscope An electrically-powered endoscope with a rigid inserted portion (which may have a flexible-tip) intended for visual examination and treatment of the cervix canal and uterine cavity (uterus), or for removal of an early or non-viable embryo/foetus upon connection to an abortion suction system. It is inserted through the vagina during hysteroscopy; some types are also intended for insertion into the female urethra during cystoscopy. An image sensor chip at the distal end of the device transmits the video images to a display monitor. It is commonly used to evaluate/treat fibroids (myomas), polyps, or conditions related to the menstrual period (e.g., menorrhagia). This is a single-use device.
Regulatory Flags# DUNS number 829616478 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850033976373 HERizon Vista ViewPoint Endoscopic Video Image Processor JY-MIP-3000 JY-MIP-3000 2026-04-01 00850033976380 HERizon Vista Single Use Hysteroscope, Diagnostic SH-02A SH-02A 2026-04-01 00850033976397 HERizon Vista Single Use Hysteroscope, Model 2 SH-02B SH-02B 2026-04-01 00850033976403 HERizon Vista Single Use Hysteroscope, Plus SH-04B SH-04B 2026-04-01 00850033976410 HERizon Vista Single Use Hysteroscope, Pro SH-03C 2026-04-01 00850033976359 HERizon Disposable Endoscopic Scissors XL JY-JD-17-450-B JY-JD-17-450-B 2026-02-13 00850033976342 Symphion Operative Hysteroscopy System Prime Controller- Refurbished FG-PRIME25-R FG-PRIME25-R 2026-02-13 10850033976356 HERizon Disposable Endoscopic Scissors XL JY-JD-17-450-B JY-JD-17-450-B 2026-02-13 00850033976366 HERizon Disposable Endoscopic Forceps – Alligator XL JY-CC-450-18-S JY-CC-450-18-S 2026-02-12 00850033976335 Symphion Operative Hysteroscopy System Prime Controller FG-PRIME25 FG-PRIME25 2025-10-31 00850033976298 HERizon Disposable Endoscopic Forceps – Alligator JY-CC-350-18-S JY-CC-350-18-S 2024-10-07 00850033976311 HERizon Disposable Endoscopic Scissors JY-JD-17-350-B JY-JD-17-350-B 2024-10-07 00850033976267 HERizon Disposable Electronic Hysteroscope JY-DEH-001 JY-DEH-001 2024-10-07 00850033976274 HERizon Disposable Endoscopic Forceps - Biopsy JY-PK-350-18-S JY-PK-350-18-S 2024-10-07 00850033976281 HERizon Disposable Endoscopic Forceps - Foreign Body Grasper JY-C-350-18-S JY-C-350-18-S 2024-10-07 00850033976304 HERizon Disposable Endoscopic Forceps - Inverted Tooth JY-DC-350-18-S JY-DC-350-18-S 2024-10-07 00850033976250 HERizon Medical Endoscope Image Processor JY-MIP-1000 JY-MIP-1000 2024-10-07 10850033976271 HERizon Disposable Endoscopic Forceps - Biopsy JY-PK-350-18-S JY-PK-350-18-S 2024-10-07 10850033976288 HERizon Disposable Endoscopic Forceps - Foreign Body Grasper JY-C-350-18-S JY-C-350-18-S 2024-10-07 10850033976295 HERizon Disposable Endoscopic Forceps – Alligator JY-CC-350-18-S JY-CC-350-18-S 2024-10-07
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