GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs IL-100-100-000

GUDID 17290018240011

GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs

ILLUMIGYN LTD

Video colposcope camera/monitor

• Primary Device ID: 17290018240011
• NIH Device Record Key: 785cfc7e-4744-43a5-9a8b-8dd7be64765d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs
• Version Model Number: 01
• Catalog Number: IL-100-100-000
• Company DUNS: 600627621
• Company Name: ILLUMIGYN LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com
• Phone: +97225476319
• Email: support@illumigyn.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290018240011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190187

FDA Product Code

• HEX: Colposcope (And Colpomicroscope)

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: 2020-11-30
• Device Publish Date: 2020-11-20

Devices Manufactured by ILLUMIGYN LTD

• 57290018240026 - Gynescope, console system: 2020-12-04 Gynescope™ system console for image capturing and digital image archiving
• 67290018240016 - Gynescope Image acquistion system: 2020-12-04 The Gynescope™ is an imaging colposcope. The Gynescope™ provides high resolution imaging optics comprised of multi-spectral
• 77290018240013 - Gynescope system, cart: 2020-12-04 Gynescope system, cart
• 17290018240011 - GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs: 2020-11-30GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs
• 17290018240011 - GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs: 2020-11-30 GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs
• 27290018240018 - Gynescope single use vaginal speculume size small 60 units: 2020-10-05 Indications for Use Gynescope single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expo
• 37290018240015 - Gynescope single use vaginal speculum size medium 60 units: 2020-10-05 Indications for Use Gynescope Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expo
• 47290018240012 - Gynescope single use vaginal speculum size large 60 units: 2020-10-05 Indications for Use Gynescope Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expo
• 57290018240019 - Gynescope single use vaginal speculum size Sm + Md + Lrg 20 pcs each: 2020-10-05 20 units with small size 20 units with medium size 20 units with lager size. Indications for Use Gynescope Single Use Vaginal Sp