| Primary Device ID | 00871321002611 |
| NIH Device Record Key | c8408146-e05a-446a-8373-1232ac00f163 |
| Commercial Distribution Discontinuation | 2021-01-26 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Gonio Left |
| Version Model Number | LGP2000-OS |
| Company DUNS | 248911026 |
| Company Name | Labtician Ophthalmics, Inc |
| Device Count | 1 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00871321002611 [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 | 4 |
| Public Version Date | 2021-01-27 |
| Device Publish Date | 2015-10-05 |
| 00871321000297 - Labtician Lid Load Adhesive Strips | 2021-08-11 Adhesive Strips used to adhere weight to the outer skin of the upper eyelid. |
| 00871321002956 - LLL Proportional 2.0 grams | 2021-04-30 |
| 10871321001369 - Grooved Sponge | 2021-01-28 |
| 10871321001628 - Silicone Tire 10mm | 2021-01-28 |
| 10871321001635 - Meridional Implant - Flat | 2021-01-28 |
| 10871321001642 - Silicone Tire 7mm | 2021-01-28 |
| 10871321001659 - Circling Band | 2021-01-28 |
| 10871321001666 - 2.5mm Circling Band | 2021-01-28 2.5mm Circling Band |