GynoVision

Basic Information

• Brand Name: GynoVision
• Primary DI: 06946332802193
• Version / Model: JSX-T-7
• Company Name: Chongqing Jinshan Science & Technology (Group) Co., Ltd
• Labeler DUNS: 545245755
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-01
• Public Version: 1
• Public Version Date: 2020-09-09
• Public Version Status: New
• Public Device Record Key: 1c014eef-429e-4cc5-b7d6-c2bd19b1283c
• Distribution End Date: 2030-01-01

Device Description

Disposable Hysteroscopic Cannula, 1 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: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HGH	Cannula, Suction, Uterine	Obstetrics/Gynecology	884.5070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63256	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	06946332802209	GS1	box	10	Not in Commercial Distribution	2020-08-01
Primary	06946332802193	GS1
Package	06946332802216	GS1	box	10	Not in Commercial Distribution	2020-08-01

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K172151	000