| Primary Device ID | 08526830083300 |
| NIH Device Record Key | b537c84c-c5c8-4188-b882-e37e365c44f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IS-5000 |
| Version Model Number | 23070-11-001 |
| 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 | 08526830083300 [Primary] |
| HMF | Stand, Instrument, Ac-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 |
| 08526830083317 | IS-5000 INSTRUMENT STAND 220 VOLT; AC-Powered Ophthalmic Instrument Stand |
| 08526830083300 | IS-5000 INSTRUMENT STAND 110/120 VOLT; AC-Powered Ophthalmic Instrument Stand |
| 00852683007155 | IS-5000 INSTRUMENT STAND 220 VOLT; AC-Powered Ophthalmic Instrument Stand |
| 00852683007148 | IS-5000 INSTRUMENT STAND 110/120 VOLT; AC-Powered Ophthalmic Instrument Stand |