| Primary Device ID | 00684995540095 | 
| NIH Device Record Key | b1a0bcf7-32c9-4783-8965-b7f0e768c3ec | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Silicone Tubing, Radiopaque | 
| Version Model Number | GS75160-51 | 
| 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 | 00684995540095 [Primary] | 
| 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 |