Visi-Pro™

GUDID 00643169788039

PXB35-10-37-080 STENT VISI PRO 035 V01

Covidien LP

Multiple peripheral artery stent, bare-metal
Primary Device ID00643169788039
NIH Device Record Key69137052-667a-4760-b08f-0746d96808db
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisi-Pro™
Version Model NumberPXB35-10-37-080
Company DUNS968903703
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge7 French
Device Size Text, specify0
Length37 Millimeter
Outer Diameter10 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169788039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGEStents, drains and dilators for the biliary ducts

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-10
Device Publish Date2018-09-09

On-Brand Devices [Visi-Pro™]

00643169788060PXB35-10-57-135 STENT VISI PRO 035 V01
00643169788053PXB35-10-57-080 STENTVISI PRO 035 V01
00643169788046PXB35-10-37-135 STENT VISI PRO 035 V01
00643169788039PXB35-10-37-080 STENT VISI PRO 035 V01
00643169788022PXB35-10-27-135 STENT VISI PRO 035 V01
00643169788015PXB35-10-27-080 STENT VISI PRO 035 V01
00643169788008PXB35-10-17-135 STENT VISI PRO 035 V01
00643169787995PXB35-10-17-080 STENT VISI PRO 035 V01
00643169787988PXB35-09-57-135 STENT VISI PRO 035 V01
00643169787971PXB35-09-57-080 STENT VISI PRO 035 V01
00643169787964PXB35-09-37-135 STENT VISI PRO 035 V01
00643169787957PXB35-09-37-080 STENT VISI PRO 035 V01
00643169787940PXB35-09-27-135 STENT VISI PRO 035 V01
00643169787933PXB35-09-27-080 STENT VISI PRO 035 V01
00643169787926PXB35-09-17-135 STENT VISI PRO 035 V01
00643169787919PXB35-09-17-080 STENT VISI PRO 035 V01
00643169787902PXB35-08-57-135 STENT VISI PRO 035 V01
00643169787896PXB35-08-57-080 STENT VISI PRO 035 V01
00643169787889PXB35-08-37-135 STENT VISI PRO 035 V01
00643169787872PXB35-08-37-080 STENTVISI PRO 035 V01
00643169787865PXB35-08-27-135 STENT VISI PRO 035 V01
00643169787858PXB35-08-27-080 STENT VISI PRO 035 V01
00643169787841PXB35-08-17-135 STENT VISI PRO 035 V01
00643169787834PXB35-08-17-080 STENT VISI PRO 035 V01
00643169787827PXB35-07-57-135 STENT VISI PRO 035 V01
00643169787810PXB35-07-57-080 STENT VISI PRO 035 V01
00643169787803PXB35-07-37-135 STENT VISI PRO 035 V01
00643169787797PXB35-07-37-080 STENT VISI PRO 035 V01
00643169787780PXB35-07-27-135 STENT VISI PRO 035 V01
00643169787773PXB35-07-27-080 STENT VISI PRO 035 V01
00643169787766PXB35-07-17-135 STENT VISI PRO 035 V01
00643169787759PXB35-07-17-080 STENT VISI PRO 035 V01
00643169787742PXB35-07-12-080 STENT VISI PRO 035 V01
00643169787735PXB35-06-57-135 STENT VISI PRO 035 V01
00643169787728PXB35-06-57-080 STENT VISI PRO 035 V01
00643169787711PXB35-06-37-135 STENT VISI PRO 035 V01
00643169787704PXB35-06-37-080 STENT VISI PRO 035 V01
00643169787698PXB35-06-27-135 STENT VISI PRO 035 V01
00643169787681PXB35-06-27-080 STENT VISI PRO 035 V01
00643169787674PXB35-06-17-135 STENT VISI PRO 035 V01
00643169787667PXB35-06-17-080 STENT VISI PRO 035 V01
00643169787650PXB35-06-12-080 STENT VISI PRO 035 V01
00643169787643PXB35-05-57-135 STENT VISI PRO 035 V01
00643169787636PXB35-05-57-080 STENTVISI PRO 035 V01
00643169787629PXB35-05-37-135 STENT VISI PRO 035 V01
00643169787612PXB35-05-37-080 STENT VISI PRO 035 V01
00643169787605PXB35-05-27-135 STENT VISI PRO 035 V01
00643169787599PXB35-05-27-080 STENT VISI PRO 035 V01
00643169787582PXB35-05-17-135 STENT VISI PRO 035 V01
00643169787575PXB35-05-17-080 STENT VISI PRO 035 V01

Trademark Results [Visi-Pro]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VISI-PRO
VISI-PRO
77357343 3476202 Live/Registered
ev3 Endovascular, Inc.
2007-12-20

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