| Primary Device ID | 20194717102479 |
| NIH Device Record Key | 346c03c5-ccbf-4816-bc5a-19263ddcba35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Regard™ |
| Version Model Number | GS00003S |
| Company DUNS | 117174678 |
| Company Name | ROI CPS, LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |