| Primary Device ID | 00850003069616 |
| NIH Device Record Key | b881208d-e8c7-406a-8709-03ef278de408 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AIT-250R |
| Version Model Number | 25042-11-002 |
| Company DUNS | 053547238 |
| Company Name | TOPCON HEALTHCARE 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850003069616 [Primary] |
| HRJ | Table, Instrument, Powered, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-25 |
| Device Publish Date | 2025-07-17 |
| 00850053428708 - OC-2200 | 2025-09-26 OC-2200 CHAIR AUTUMN LEAF 110V HIGH; Ophthalmic examination chair |
| 00850053428715 - OC-2200 | 2025-09-26 OC-2200 CHAIR AUTUMN LEAF 110V LOW; Ophthalmic examination chair |
| 00850053428722 - OC-2200 | 2025-09-26 OC-2200 CHAIR AUTUMN LEAF 220V HIGH; Ophthalmic examination chair |
| 00850053428739 - OC-2200 | 2025-09-26 OC-2200 CHAIR AUTUMN LEAF 220V LOW; Ophthalmic examination chair |
| 00850053428647 - OC-2300 | 2025-09-11 OC-2300 CHAIR WHITE 120 VOLT LOW; Ophthalmic examination chair |
| 00850053428654 - OC-2300 | 2025-09-11 OC-2300 CHAIR WHITE 120 VOLT HIGH; Ophthalmic examination chair |
| 00850053428661 - OC-2200 | 2025-09-11 OC-2200 CHAIR WHITE 120 VOLT LOW; Ophthalmic examination chair |
| 00850053428678 - OC-2200 | 2025-09-11 OC-2200 CHAIR WHITE 120 VOLT HIGH; Ophthalmic examination chair |