| Primary Device ID | 05056080500249 |
| NIH Device Record Key | 7757a111-1d9e-4e5d-a98f-11ce97cf31dd |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | R30957001 |
| Company DUNS | 232600853 |
| Company Name | REMEL EUROPE LIMITED |
| 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 | 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 |