| Primary Device ID | 00643169787599 | 
| NIH Device Record Key | d0e70531-fd03-43c8-bdb1-98263685e954 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Visi-Pro™ | 
| Version Model Number | PXB35-05-27-080 | 
| Company DUNS | 968903703 | 
| Company Name | Covidien LP | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | MR Conditional | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Outer Diameter | 5 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Device Size Text, specify | 0 | 
| Length | 27 Millimeter | 
| Catheter Gauge | 6 French | 
| Outer Diameter | 5 Millimeter | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00643169787599 [Primary] | 
| FGE | Stents, drains and dilators for the biliary ducts | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2018-10-10 | 
| Device Publish Date | 2018-09-09 | 
| 00643169788060 | PXB35-10-57-135 STENT VISI PRO 035 V01 | 
| 00643169788053 | PXB35-10-57-080 STENTVISI PRO 035 V01 | 
| 00643169788046 | PXB35-10-37-135 STENT VISI PRO 035 V01 | 
| 00643169788039 | PXB35-10-37-080 STENT VISI PRO 035 V01 | 
| 00643169788022 | PXB35-10-27-135 STENT VISI PRO 035 V01 | 
| 00643169788015 | PXB35-10-27-080 STENT VISI PRO 035 V01 | 
| 00643169788008 | PXB35-10-17-135 STENT VISI PRO 035 V01 | 
| 00643169787995 | PXB35-10-17-080 STENT VISI PRO 035 V01 | 
| 00643169787988 | PXB35-09-57-135 STENT VISI PRO 035 V01 | 
| 00643169787971 | PXB35-09-57-080 STENT VISI PRO 035 V01 | 
| 00643169787964 | PXB35-09-37-135 STENT VISI PRO 035 V01 | 
| 00643169787957 | PXB35-09-37-080 STENT VISI PRO 035 V01 | 
| 00643169787940 | PXB35-09-27-135 STENT VISI PRO 035 V01 | 
| 00643169787933 | PXB35-09-27-080 STENT VISI PRO 035 V01 | 
| 00643169787926 | PXB35-09-17-135 STENT VISI PRO 035 V01 | 
| 00643169787919 | PXB35-09-17-080 STENT VISI PRO 035 V01 | 
| 00643169787902 | PXB35-08-57-135 STENT VISI PRO 035 V01 | 
| 00643169787896 | PXB35-08-57-080 STENT VISI PRO 035 V01 | 
| 00643169787889 | PXB35-08-37-135 STENT VISI PRO 035 V01 | 
| 00643169787872 | PXB35-08-37-080 STENTVISI PRO 035 V01 | 
| 00643169787865 | PXB35-08-27-135 STENT VISI PRO 035 V01 | 
| 00643169787858 | PXB35-08-27-080 STENT VISI PRO 035 V01 | 
| 00643169787841 | PXB35-08-17-135 STENT VISI PRO 035 V01 | 
| 00643169787834 | PXB35-08-17-080 STENT VISI PRO 035 V01 | 
| 00643169787827 | PXB35-07-57-135 STENT VISI PRO 035 V01 | 
| 00643169787810 | PXB35-07-57-080 STENT VISI PRO 035 V01 | 
| 00643169787803 | PXB35-07-37-135 STENT VISI PRO 035 V01 | 
| 00643169787797 | PXB35-07-37-080 STENT VISI PRO 035 V01 | 
| 00643169787780 | PXB35-07-27-135 STENT VISI PRO 035 V01 | 
| 00643169787773 | PXB35-07-27-080 STENT VISI PRO 035 V01 | 
| 00643169787766 | PXB35-07-17-135 STENT VISI PRO 035 V01 | 
| 00643169787759 | PXB35-07-17-080 STENT VISI PRO 035 V01 | 
| 00643169787742 | PXB35-07-12-080 STENT VISI PRO 035 V01 | 
| 00643169787735 | PXB35-06-57-135 STENT VISI PRO 035 V01 | 
| 00643169787728 | PXB35-06-57-080 STENT VISI PRO 035 V01 | 
| 00643169787711 | PXB35-06-37-135 STENT VISI PRO 035 V01 | 
| 00643169787704 | PXB35-06-37-080 STENT VISI PRO 035 V01 | 
| 00643169787698 | PXB35-06-27-135 STENT VISI PRO 035 V01 | 
| 00643169787681 | PXB35-06-27-080 STENT VISI PRO 035 V01 | 
| 00643169787674 | PXB35-06-17-135 STENT VISI PRO 035 V01 | 
| 00643169787667 | PXB35-06-17-080 STENT VISI PRO 035 V01 | 
| 00643169787650 | PXB35-06-12-080 STENT VISI PRO 035 V01 | 
| 00643169787643 | PXB35-05-57-135 STENT VISI PRO 035 V01 | 
| 00643169787636 | PXB35-05-57-080 STENTVISI PRO 035 V01 | 
| 00643169787629 | PXB35-05-37-135 STENT VISI PRO 035 V01 | 
| 00643169787612 | PXB35-05-37-080 STENT VISI PRO 035 V01 | 
| 00643169787605 | PXB35-05-27-135 STENT VISI PRO 035 V01 | 
| 00643169787599 | PXB35-05-27-080 STENT VISI PRO 035 V01 | 
| 00643169787582 | PXB35-05-17-135 STENT VISI PRO 035 V01 | 
| 00643169787575 | PXB35-05-17-080 STENT VISI PRO 035 V01 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  VISI-PRO  77357343  3476202 Live/Registered | ev3 Endovascular, Inc. 2007-12-20 |