| Primary Device ID | 08526830083515 |
| NIH Device Record Key | 474a8bb3-68fb-40c6-8ec2-9f87a5623a53 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AIT-250W |
| Version Model Number | 25042-22-001 |
| Company DUNS | 053547238 |
| Company Name | TOPCON MEDICAL SYSTEMS, 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 | 08526830083515 [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 | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| 08526830083515 | AIT-250W INSTRUMENT TABLE-220/240 VOLT; AC-Powered Ophthalmic Instrument Table |
| 08526830083508 | AIT-250W INSTRUMENT TABLE-110/120 VOLT; AC-Powered Ophthalmic Instrument Table |
| 00852683007216 | AIT-250W INSTRUMENT TABLE-220/240 VOLT; AC-Powered Ophthalmic Instrument Table |
| 00852683007209 | AIT-250W INSTRUMENT TABLE-110/120 VOLT; AC-Powered Ophthalmic Instrument Table |