| Primary Device ID | 67290018240016 |
| NIH Device Record Key | 39c73110-d6e6-4201-bb5f-6463d57cf6eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gynescope Image acquistion system |
| Version Model Number | 01 |
| Catalog Number | IL-100-100-200 |
| 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 |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com | |
| Phone | +97225476319 |
| Support@illumigyn.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 67290018240016 [Primary] |
| HEX | Colposcope (And Colpomicroscope) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-04 |
| Device Publish Date | 2020-11-26 |
| 57290018240026 - Gynescope, console system | 2020-12-04 Gynescope™ system console for image capturing and digital image archiving |
| 67290018240016 - Gynescope Image acquistion system | 2020-12-04The Gynescope™ is an imaging colposcope. The Gynescope™ provides high resolution imaging optics comprised of multi-spectral (White and Green) illumination and multi-angle illumination dark field (side illumination) and bright field (centered illumination) techniques, reinforced with dual imaging sensor design (a color imaging sensor and a high sensitivity monochrome sensor). The monochrome sensor and the color sensor have the same optical path. The optical design uses a beam splitter adjacent to both of the sensors (at the end of the optical path). The Gynescope™ is a compact colposcope platform for physicians to perform examinations of the cervix, combined with a working space for interventional procedures. The Gynescope™ includes an Image Acquisition System |
| 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 | 2020-11-30 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 |