Visi-Pro™

GUDID 00643169787797

PXB35-07-37-080 STENT VISI PRO 035 V01

Covidien LP

Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Multiple peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal Peripheral artery stent, bare-metal

• Primary Device ID: 00643169787797
• NIH Device Record Key: b2a21a31-6aac-4f39-8a8f-a40bda764669
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visi-Pro™
• Version Model Number: PXB35-07-37-080
• 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

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 7 Millimeter
• Catheter Gauge: 6 French
• Length: 37 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169787797 [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