| Primary Device ID | 08809783490532 |
| NIH Device Record Key | edaf8aaf-0725-460d-8c49-ef47b6ebb0cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 4PLY SURGICAL MASK |
| Version Model Number | FM-EU2002 |
| Company DUNS | 690513726 |
| Company Name | UNICO GLOBAL INC |
| Device Count | 50 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |