Visi-Pro PXB35-10-27-080
GUDID 00821684036648
Balloon-Expandable Biliary Stent System
Covidien LP
Bare-metal biliary stent| Primary Device ID | 00821684036648 |
| NIH Device Record Key | acc617a7-54c6-4094-9356-c5d14eeb77ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Visi-Pro |
| Version Model Number | PXB35-10-27-080 |
| Catalog Number | PXB35-10-27-080 |
| Company DUNS | 968903703 |
| Company Name | Covidien LP |
| 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 | false |
| Expiration Date | true |
| 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
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Outer Diameter | 10 Millimeter |
| Length | 27 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| 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 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 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 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 dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684036648 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061566
FDA Product Code
| FGE | CATHETER, BILIARY, DIAGNOSTIC |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [Visi-Pro]
| 00821684036693 | Balloon-Expandable Biliary Stent System |
| 00821684036686 | Balloon-Expandable Biliary Stent System |
| 00821684036679 | Balloon-Expandable Biliary Stent System |
| 00821684036662 | Balloon-Expandable Biliary Stent System |
| 00821684036655 | Balloon-Expandable Biliary Stent System |
| 00821684036648 | Balloon-Expandable Biliary Stent System |
| 00821684036631 | Balloon-Expandable Biliary Stent System |
| 00821684036624 | Balloon-Expandable Biliary Stent System |
| 00821684036617 | Balloon-Expandable Biliary Stent System |
| 00821684036600 | Balloon-Expandable Biliary Stent System |
| 00821684036594 | Balloon-Expandable Biliary Stent System |
| 00821684036587 | Balloon-Expandable Biliary Stent System |
| 00821684036570 | Balloon-Expandable Biliary Stent System |
| 00821684036563 | Balloon-Expandable Biliary Stent System |
| 00821684036556 | Balloon-Expandable Biliary Stent System |
| 00821684036549 | Balloon-Expandable Biliary Stent System |
| 00821684036532 | Balloon-Expandable Biliary Stent System |
| 00821684036525 | Balloon-Expandable Biliary Stent System |
| 00821684036518 | Balloon-Expandable Biliary Stent System |
| 00821684036501 | Balloon-Expandable Biliary Stent System |
| 00821684036495 | Balloon-Expandable Biliary Stent System |
| 00821684036488 | Balloon-Expandable Biliary Stent System |
| 00821684036471 | Balloon-Expandable Biliary Stent System |
| 00821684036464 | Balloon-Expandable Biliary Stent System |
| 00821684036457 | Balloon-Expandable Biliary Stent System |
| 00821684036440 | Balloon-Expandable Biliary Stent System |
| 00821684036433 | Balloon-Expandable Biliary Stent System |
| 00821684036426 | Balloon-Expandable Biliary Stent System |
| 00821684036419 | Balloon-Expandable Biliary Stent System |
| 00821684036402 | Balloon-Expandable Biliary Stent System |
| 00821684036396 | Balloon-Expandable Biliary Stent System |
| 00821684036389 | Balloon-Expandable Biliary Stent System |
| 00821684036372 | Balloon-Expandable Biliary Stent System |
| 00821684036365 | Balloon-Expandable Biliary Stent System |
| 00821684036358 | Balloon-Expandable Biliary Stent System |
| 00821684036341 | Balloon-Expandable Biliary Stent System |
| 00821684036334 | Balloon-Expandable Biliary Stent System |
| 00821684036327 | Balloon-Expandable Biliary Stent System |
| 00821684036310 | Balloon-Expandable Biliary Stent System |
| 00821684036303 | Balloon-Expandable Biliary Stent System |
| 00821684036297 | Balloon-Expandable Biliary Stent System |
| 00821684036280 | Balloon-Expandable Biliary Stent System |
| 00821684036273 | Balloon-Expandable Biliary Stent System |
| 00821684036266 | Balloon-Expandable Biliary Stent System |
| 00821684036259 | Balloon-Expandable Biliary Stent System |
| 00821684036242 | Balloon-Expandable Biliary Stent System |
| 00821684036235 | Balloon-Expandable Biliary Stent System |
| 00821684036228 | Balloon-Expandable Biliary Stent System |
| 00821684036211 | Balloon-Expandable Biliary Stent System |
| 00821684036204 | Balloon-Expandable Biliary Stent System |
Trademark Results [Visi-Pro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VISI-PRO 77357343 3476202 Live/Registered |
ev3 Endovascular, Inc. 2007-12-20 |
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