| Primary Device ID | 18713210001789 |
| NIH Device Record Key | f30b54d1-d054-454b-bc1f-8252cbcf98a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone Strip |
| Version Model Number | S 2998 |
| Company DUNS | 248911026 |
| Company Name | Labtician Ophthalmics, Inc |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08713210000648 [Unit of Use] |
| GS1 | 18713210001789 [Primary] |
| HQJ | Implant, Absorbable, (Scleral Buckling Methods) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-09 |
| 18713210002267 | S 4060 |
| 18713210001987 | S 4065 |
| 18713210001970 | S 4055 |
| 18713210001963 | S 4050 |
| 18713210001789 | S 2998 |
| 18713210001703 | S 2992 |
| 18713210001604 | S 2971 |
| 18713210001598 | S 2970 |
| 18713210001574 | S 2968 |
| 18713210001567 | S 2967 |
| 18713210001550 | S 2965 |
| 10871321001604 | S 2971 |
| 10871321001598 | S 2970 |
| 10871321001574 | S 2968 |
| 10871321001567 | S 2967 |
| 10871321001550 | S 2965 |
| 10871321002267 | S 4060 |
| 10871321001987 | S 4065 |
| 10871321001970 | S 4055 |
| 10871321001963 | S 4050 |
| 10871321001789 | S 2998 |
| 10871321001703 | S 2992 |