Visi-Pro™
GUDID 00643169787872
PXB35-08-37-080 STENTVISI PRO 035 V01
Covidien LP
Multiple peripheral artery stent, bare-metal| Primary Device ID | 00643169787872 |
| NIH Device Record Key | 0b8b846c-4e1c-4ceb-b15e-ad119b1a4abd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Visi-Pro™ |
| Version Model Number | PXB35-08-37-080 |
| 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 |
Customer Support Contacts
Device Dimensions
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Outer Diameter | 8 Millimeter |
| Length | 37 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169787872 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P030045
FDA Product Code
| FGE | Stents, drains and dilators for the biliary ducts |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-10 |
| Device Publish Date | 2018-09-09 |
On-Brand Devices [Visi-Pro™]
| 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 |
Trademark Results [Visi-Pro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VISI-PRO 77357343 3476202 Live/Registered |
ev3 Endovascular, Inc. 2007-12-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.