| Primary Device ID | 27290018240018 |
| NIH Device Record Key | 92b54960-f68e-4efe-bbad-38fba85ea908 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gynescope single use vaginal speculume size small 60 units |
| Version Model Number | 01 |
| Catalog Number | IL-100-200-210 |
| Company DUNS | 600627621 |
| Company Name | ILLUMIGYN LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 27290018240018 [Primary] |
| HIB | Speculum, Vaginal, Nonmetal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-05 |
| Device Publish Date | 2020-09-25 |
| 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 | 2020-10-05Indications for Use Gynescope single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope™ system. |
| 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 |