| Primary Device ID | 10816908010815 |
| NIH Device Record Key | 3af0f2bb-75f6-4e49-8dfc-6e1fab2f4c4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gynex SpecuLume EZ |
| Version Model Number | 7-64553 |
| Catalog Number | 7-64553 |
| Company DUNS | 154779748 |
| Company Name | CYALUME TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-888-733-4034 |
| info@cyalumemed.com |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816908010818 [Primary] |
| GS1 | 10816908010815 [Package] Contains: 00816908010818 Package: Box [25 Units] In Commercial Distribution |
| HIB | Speculum, Vaginal, Nonmetal |
| HIC | Speculum, Vaginal, Nonmetal, Fiberoptic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-03 |
| Device Publish Date | 2019-10-16 |
| 10816908010815 | Self Illuminated Vaginal Speculum (Large, Screw Closure, Elevating) |
| 00816908010801 | Self Illuminated Vaginal Speculum (Medium, Screw Closure, Elevating) |
| 10816908010792 | Self Illuminated Vaginal Speculum (Small, Screw Closure, Elevating) |