| Primary Device ID | 00848838057991 |
| NIH Device Record Key | c09d7b5a-9bf5-47d1-a0b1-8f0ffb4af3d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Remel Inc |
| Version Model Number | R8311001 |
| Company DUNS | 065769564 |
| Company Name | REMEL, INC. |
| Device Count | 20 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 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 | false |
| OTC Over-The-Counter | false |