| Primary Device ID | 00850053428616 |
| NIH Device Record Key | af6af5f2-e362-41ed-8552-4fd0e53e02ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IS-5500 |
| Version Model Number | 23060-11-000-GV |
| 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 |
| 08526830083232 | IS-5500 OPHTHALMIC INST. STAND W/DLRL 22; AC-Powered Ophthalmic Instrument Stand |
| 08526830083225 | IS-5500 INSTRUMENT STAND 220/240 VOLT; AC-Powered Ophthalmic Instrument Stand |
| 08526830083218 | IS-5500 OPHTHALMIC INST. STAND W/DLRL 11; AC-Powered Ophthalmic Instrument Stand |
| 08526830083201 | IS-5500 INSTRUMENT STAND 110/120 VOLT; AC-Powered Ophthalmic Instrument Stand |
| 00852683007131 | IS-5500 OPHTHALMIC INST. STAND W/DLRL 22; AC-Powered Ophthalmic Instrument Stand |
| 00852683007124 | IS-5500 INSTRUMENT STAND 220/240 VOLT; AC-Powered Ophthalmic Instrument Stand |
| 00852683007117 | IS-5500 OPHTHALMIC INST. STAND W/DLRL 11; AC-Powered Ophthalmic Instrument Stand |
| 00852683007100 | IS-5500 INSTRUMENT STAND 110/120 VOLT; AC-Powered Ophthalmic Instrument Stand |
| 00850053428616 | IS-5500 OPHTHALMIC STAND GRAND VISION 110V; AC-Powered Ophthalmic Instrument Stand |