| Primary Device ID | G568V2627 |
| NIH Device Record Key | 8d638707-2254-49ef-8c2b-cfb789f64158 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scleral Shell |
| Version Model Number | V2627 |
| Company DUNS | 941542953 |
| Company Name | THOMPSON OCULAR PROSTHETICS, 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com | |
| Phone | 2102233754 |
| jthompson@thompsonocular.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G568V2627 [Primary] |
| HQT | Shell, Scleral |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-18 |
| Device Publish Date | 2025-03-10 |
| G568V2623 - Artificial Eye, Plastic, Custom | 2025-03-18 |
| G568V2627 - Scleral Shell | 2025-03-18 |
| G568V2627 - Scleral Shell | 2025-03-18 |
| G568V2628 - Ophthalmic Conformer | 2025-03-18 |