| Primary Device ID | 00860013046415 |
| NIH Device Record Key | f4c27f71-290d-4b5d-b22b-ef20ae7e1b03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TearRepair |
| Version Model Number | TR100 |
| Company DUNS | 026944109 |
| Company Name | Optmed Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00860013046408 [Package] Package: [5 Units] In Commercial Distribution |
| GS1 | 00860013046415 [Primary] |
| GS1 | 10860013046405 [Package] Contains: 00860013046408 Package: [10 Units] In Commercial Distribution |
| KMF | Bandage, Liquid |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-09 |
| Device Publish Date | 2025-05-30 |