Gynescope system, cart

Basic Information

• Brand Name: Gynescope system, cart
• Primary DI: 77290018240013
• Version / Model: 01
• Catalog Number: IL-100-100-900
• Company Name: ILLUMIGYN LTD
• Labeler DUNS: 600627621
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-26
• Public Version: 2
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 94d7f38b-78a0-42e6-8b9d-ef69c4638eee

Device Description

Gynescope system, cart

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HEX	Colposcope (And Colpomicroscope)	Obstetrics/Gynecology	884.1630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64925	Video colposcope camera/display unit	An electrically-powered device intended to be placed in a video colposcope speculum (not included) to record and display images and videos during examination of the tissues of the vagina, cervix, and external genitalia. It typically consists of an illuminated lens and video camera unit connected to an image display screen/monitor with incorporated software for receiving and viewing the transmitted images/videos. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	77290018240013	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190187	000