| Primary Device ID | 10871321002526 |
| NIH Device Record Key | 0b5598a3-6f9c-4a52-8852-933e02a51777 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LabVit Kit |
| Version Model Number | LVK1000, LVK1100 |
| Catalog Number | N/A |
| Company DUNS | 248911026 |
| Company Name | Labtician Ophthalmics, 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 | true |
| 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 | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com | |
| Phone | 905-829-0055 |
| philcuscuna@labtician.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10871321002526 [Primary] |
| KDD | Kit, Surgical Instrument, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-01-28 |
| Device Publish Date | 2018-02-26 |
| 18713210002526 | Disposable Intravitreal Injection Kit. |
| 10871321002526 | Disposable Intravitreal Injection Kit. |