| Primary Device ID | 04562123289046 |
| NIH Device Record Key | e28bf35f-6dd6-49fd-b3af-c24a8c1995e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plu |
| Version Model Number | DRI OCT Triton(plus) |
| Company DUNS | 690542881 |
| Company Name | TOPCON CORPORATION |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04562123289046 [Primary] |
| HKI | Camera, ophthalmic, ac-powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-08-27 |
| Device Publish Date | 2018-02-07 |
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