Primary Device ID | 00684995500181 |
NIH Device Record Key | 5a26f550-789f-4853-b491-1648f4a7b730 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Silicone Biliary Stent |
Version Model Number | GR83064-20SP |
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 | 00684995500181 [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 |