| Primary Device ID | 57290018240026 |
| NIH Device Record Key | 6451e6cf-7feb-454e-ab89-797e7bb88aa7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gynescope, console system |
| Version Model Number | 01 |
| Catalog Number | IL-100-100-100 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 57290018240026 [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 | 2020-12-04Gynescope™ system console for image capturing and digital image archiving |
| 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 | 2020-11-30 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 |