| Primary Device ID | 00850053428708 |
| NIH Device Record Key | 97ed8da5-2222-4cff-add9-84cec9859355 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OC-2200 |
| Version Model Number | 24046-AU-H1-000 |
| 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 | 00850053428708 [Primary] |
| HME | Chair, Ophthalmic, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-26 |
| Device Publish Date | 2025-09-18 |
| 00850053428678 | OC-2200 CHAIR WHITE 120 VOLT HIGH; Ophthalmic examination chair |
| 00850053428661 | OC-2200 CHAIR WHITE 120 VOLT LOW; Ophthalmic examination chair |
| 00850053428739 | OC-2200 CHAIR AUTUMN LEAF 220V LOW; Ophthalmic examination chair |
| 00850053428722 | OC-2200 CHAIR AUTUMN LEAF 220V HIGH; Ophthalmic examination chair |
| 00850053428715 | OC-2200 CHAIR AUTUMN LEAF 110V LOW; Ophthalmic examination chair |
| 00850053428708 | OC-2200 CHAIR AUTUMN LEAF 110V HIGH; Ophthalmic examination chair |