| Primary Device ID | 00628308210183 |
| NIH Device Record Key | 01b76d56-ce63-4bf5-ba65-5f5901cea9b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | S4 OPTIK |
| Version Model Number | ETILT-CH-H-S4 |
| Company DUNS | 247873511 |
| Company Name | Blue.S4 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 | 00628308210183 [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 | 2025-03-20 |
| Device Publish Date | 2025-03-12 |
| 00628308210114 | S4OPTIK Combination Chair & Stand - Model 2500-CB-H-L |
| 00628308210107 | S4OPTIK Combination Chair & Stand - Model 2500-CB-H |
| 00628308210084 | S4OPTIK Combination Chair & Stand - Model 2000-CB-H-L |
| 00628308210077 | S4OPTIK Combination Chair & Stand - Model 2000-CB-H |
| 00628308210053 | S4OPTIK Ophthalmic Examination Chair - Model 2000-CH-H |
| 00628308210046 | S4OPTIK Ophthalmic Examination Chair - Model 2500-CH-H |
| 00628308210022 | S4OPTIK Instrument Stand - MODEL 2000-ST |
| 00628308210183 | S4OPTIK Ophthalmic Examination Chair - ETILT-CH-H-S4 |
| 00628308210268 | S4OPTIK Combination Chair & Stand - Model 1000-CB-H-L |
| 00628308210251 | S4OPTIK Combination Chair & Stand - Model 1000-CB-H |
| 00628308210237 | S4OPTIK Ophthalmic Examination Chair - Model 1000-CH-H |
| 00628308210220 | S4OPTIK Ophthalmic Examination Chair - Model 2000-CH-H-FIX |
| 00628308210213 | S4OPTIK Ophthalmic Examination Chair - Model 2000-CH-H-CUS |
| 00628308210329 | S4OPTIK Ophthalmic Instrument Table - Model TA1S4-3UP |
| 00628308210312 | S4OPTIK Ophthalmic Instrument Table - Model TA1S4-2UP-Lx |
| 00628308210305 | S4OPTIK Ophthalmic Instrument Table - Model TA1S4-2UP |
| 00628308210398 | Chair glide for ophthalmology examination Chairs - Topcon |
| 00628308210381 | Chair glide for ophthalmology examination Chairs - S4 |
| 00628308210374 | Chair mover for ophthalmology examination Chairs |
| 00628308210367 | Ophthalmic instrument table-legs (table-top not included) |
| 00628308210350 | Ophthalmic instrument tabletop (legs not included) |
| 00628308210343 | Ophthalmic instrument tabletop with power-bar (legs not included) |
| 00628308210336 | Ophthalmic instrument tabletop with power-bar (legs not included) |