| Primary Device ID | 00684995500051 |
| NIH Device Record Key | b78af44b-8fad-4ee9-bba7-87326fa02ca4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone Biliary Stent |
| Version Model Number | GR83064-05 |
| 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 | 00684995500051 [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 |