| Primary Device ID | 10684995540306 |
| NIH Device Record Key | 1999498b-a749-44ea-b5be-5bbd2ce6afa0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone Tubing, Radiopaque |
| Version Model Number | GS75160-50SP8 |
| 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 | 00684995540309 [Primary] |
| GS1 | 10684995540306 [Package] Contains: 00684995540309 Package: [10 Units] In Commercial Distribution |
| GBX | Catheter, Irrigation |
| 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 |
| 10684995540313 | 12 Fr. x 8’’ |
| 10684995540306 | 10 Fr. x 8’’ |
| 10684995540276 | 7 Fr. x 12’’ |
| 10684995540269 | 7 Fr. x 4’’ |
| 10684995540252 | 6 Fr. x 12’’ |
| 10684995540221 | 5 Fr. x 8’’ |
| 10684995540214 | 8 Fr. x 8’’ |
| 10684995540207 | 8 Fr. x 4’’ |
| 10684995540191 | 6 Fr. x 8’’ |
| 00684995540187 | 24 Fr. x 100 cm |
| 00684995540170 | 20 Fr. x 100 cm |
| 00684995540163 | 20 Fr. x 100 cm |
| 00684995540149 | 18 Fr. x 100 cm |
| 00684995540132 | 16 Fr. x 100 cm |
| 00684995540118 | 14 Fr. x 100 cm |
| 00684995540095 | 11 Fr. x 100 cm |
| 00684995540088 | 10 Fr. x 100 cm |
| 00684995540071 | 9 Fr. x 100 cm |
| 00684995540064 | 8 Fr. x 100 cm |
| 00684995540057 | 7 Fr. x 100 cm |
| 00684995540040 | 6 Fr. x 100 cm |
| 00684995540033 | 5 Fr. x 100 cm |
| 00684995540026 | 4 Fr. x 100 cm |
| 00684995540019 | 3 Fr. x 100 cm |
| 00684995540002 | 2 Fr. x 100 cm |