| Primary Device ID | 08809295149430 |
| NIH Device Record Key | 1e4ec220-1de5-4a2d-9b26-58e64aba98e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIG-TIP™ |
| Version Model Number | BTW 1540B |
| Company DUNS | 690514869 |
| Company Name | RF Medical Co.,Ltd. |
| Device Count | 1 |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |