| Primary Device ID | 00628308210039 |
| NIH Device Record Key | 9f8a8de4-3c5c-42f4-b5dd-95d0e134e7bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Marco |
| Version Model Number | BR2-ST |
| 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 | 00628308210039 [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 | 2025-02-28 |
| Device Publish Date | 2025-02-20 |
| 00628308210091 | Marco Bravo 2 Chair - Model BR2-CH-H |
| 00628308210039 | Marco Bravo 2 Stand - Model BR2-ST |
| 00628308210190 | Marco e-tilt Chair - Model ETILT-CH-H-M |