| Primary Device ID | 08800142906541 | 
| NIH Device Record Key | 240d5ad2-cb89-4dc5-860a-50dec70133dd | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | BIG-TIP™ | 
| Version Model Number | BT+ 2005B | 
| 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 |