| Primary Device ID | 00684995510012 |
| NIH Device Record Key | 74c70624-f319-4091-801b-7ef954f80e17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone T-Tube |
| Version Model Number | SU130-1216 |
| Company DUNS | 080524654 |
| Company Name | BENTEC MEDICAL OPCO, LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00684995510012 [Primary] |
| PTT | Biliary Catheter For Irrigation And Contrast Injection, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-30 |
| Device Publish Date | 2023-10-20 |
| 00684995510104 | 7 Fr. x 12 in L |
| 00684995510098 | 5 Fr. x 12 in L |
| 00684995510081 | 3 Fr. x 12 in L |
| 00684995510074 | 2 Fr. x 12 in L |
| 00684995510067 | 16 Fr. x 12 in L |
| 00684995510050 | 14 Fr. x 12 in L |
| 00684995510043 | 12 Fr. x 12 in L |
| 00684995510036 | 10 Fr. x 12 in L |
| 00684995510029 | 8 Fr. x 12 in L |
| 00684995510012 | 6 Fr. x 12 in L |
| 00684995510005 | 4 Fr. x 12 in L |