HERizon Medical Endoscope Image Processor JY-MIP-1000

GUDID 00850033976250

Medical Endoscope Image Processor For Use with HERizon Disposable Electronic Hysteroscope.

Minerva Surgical, Inc.

Endoscopic video image processing unit

Primary Device ID	00850033976250
NIH Device Record Key	442240d3-3413-47bc-a010-05a2d6fd2301
Commercial Distribution Status	In Commercial Distribution
Brand Name	HERizon Medical Endoscope Image Processor
Version Model Number	JY-MIP-1000
Catalog Number	JY-MIP-1000
Company DUNS	829616478
Company Name	Minerva Surgical, 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	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	855-646-7874
Email	Customerservice@minervasurgical.com
Phone	855-646-7874
Email	Customerservice@minervasurgical.com
Phone	855-646-7874
Email	Customerservice@minervasurgical.com
Phone	855-646-7874
Email	Customerservice@minervasurgical.com
Phone	855-646-7874
Email	Customerservice@minervasurgical.com
Phone	855-646-7874
Email	Customerservice@minervasurgical.com
Phone	855-646-7874
Email	Customerservice@minervasurgical.com
Phone	855-646-7874
Email	Customerservice@minervasurgical.com
Phone	855-646-7874
Email	Customerservice@minervasurgical.com
Phone	855-646-7874
Email	Customerservice@minervasurgical.com

Operating and Storage Conditions

Storage Environment Atmospheric Pressure	Between 700 Millimeter of Mercury and 1060 Millimeter of Mercury
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 Millimeter of Mercury and 1060 Millimeter of Mercury
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 Millimeter of Mercury and 1060 Millimeter of Mercury
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 Millimeter of Mercury and 1060 Millimeter of Mercury
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 Millimeter of Mercury and 1060 Millimeter of Mercury
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 Millimeter of Mercury and 1060 Millimeter of Mercury
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 Millimeter of Mercury and 1060 Millimeter of Mercury
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 Millimeter of Mercury and 1060 Millimeter of Mercury
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 Millimeter of Mercury and 1060 Millimeter of Mercury
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033976250 [Primary]

FDA Product Code

HIH	Hysteroscope (And Accessories)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-10-15
Device Publish Date	2024-10-07

Devices Manufactured by Minerva Surgical, Inc.

00850033976250 - HERizon Medical Endoscope Image Processor	2024-10-15Medical Endoscope Image Processor For Use with HERizon Disposable Electronic Hysteroscope.
00850033976250 - HERizon Medical Endoscope Image Processor	2024-10-15 Medical Endoscope Image Processor For Use with HERizon Disposable Electronic Hysteroscope.
10850033976264 - HERizon Disposable Electronic Hysteroscope	2024-10-15 Disposable Electronic Hysteroscope For Use with HERizon Medical Endoscope Image Processor
10850033976271 - HERizon Disposable Endoscopic Forceps - Biopsy	2024-10-15 Disposable Endoscopic Forceps - Biopsy
10850033976288 - HERizon Disposable Endoscopic Forceps - Foreign Body Grasper	2024-10-15 Disposable Endoscopic Forceps - Foreign Body Grasper
10850033976295 - HERizon Disposable Endoscopic Forceps – Alligator	2024-10-15 Disposable Endoscopic Forceps – Alligator
10850033976301 - HERizon Disposable Endoscopic Forceps - Inverted Tooth	2024-10-15 Disposable Endoscopic Forceps - Inverted Tooth
10850033976318 - HERizon Disposable Endoscopic Scissors	2024-10-15 Disposable Endoscopic Scissors
00850033976236 - INFINITY Fluid Management Accessory	2024-08-20 Symphion Operative Hysteroscopy System, Fluid Management with filter for recirculation. For use with Symphion Controller.