| Primary Device ID | 00684995500020 | 
| NIH Device Record Key | 6d6b1994-e527-458d-a549-eb4db58f374f | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Silicone Biliary Stent | 
| Version Model Number | GR83064-01 | 
| Company DUNS | 080524654 | 
| Company Name | BENTEC MEDICAL OPCO, LLC | 
| 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 | 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 | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00684995500020 [Primary] | 
| FGE | Catheter, Biliary, Diagnostic | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2019-05-10 | 
| Device Publish Date | 2017-01-03 | 
| 00684995500204 | GR83064-056SP | 
| 00684995500198 | GR83064-26SP | 
| 00684995500181 | GR83064-20SP | 
| 00684995500174 | GR83064-13SP | 
| 00684995500167 | GR83064-10SP | 
| 00684995500150 | GR83064-07SP | 
| 00684995500143 | GR83064-04SP | 
| 00684995500136 | GR83064-02SP | 
| 00684995500129 | GR83064-11 | 
| 00684995500112 | GR83064-14 | 
| 00684995500105 | GR83064-13 | 
| 00684995500099 | GR83064-10 | 
| 00684995500082 | GR83064-07 | 
| 00684995500075 | GR83064-06 | 
| 00684995500068 | GR83064-08 | 
| 00684995500051 | GR83064-05 | 
| 00684995500044 | GR83064-04 | 
| 00684995500037 | GR83064-02 | 
| 00684995500020 | GR83064-01 | 
| 00684995500013 | GR83064-03 | 
| 00684995500006 | GR83064-12 |