Prote´ge´™ GPS™

GUDID 00643169729087

STENT SERB65-10-80-120 PROTEGE GPS V06

Covidien LP

Multiple peripheral artery stent, bare-metal

• Primary Device ID: 00643169729087
• NIH Device Record Key: 7f641064-ffe7-4f07-a3c2-9c2ff0a1d6de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prote´ge´™ GPS™
• Version Model Number: SERB65-10-80-120
• 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: 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
• 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

• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter
• Catheter Gauge: 6 French
• Length: 80 Millimeter

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
• 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	00643169729087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060001

FDA Product Code

• NIO: STENT, ILIAC

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: 2017-01-01

On-Brand Devices [Prote´ge´™ GPS™]

• 00643169729193: STENT SERB65-12-80-80 PROTEGE GPS V06
• 00643169729186: STENT SERB65-12-80-120 PROTEGE GPS V06
• 00643169729179: STENT SERB65-12-60-80 PROTEGE GPS V06
• 00643169729162: STENT SERB65-12-60-120 PROTEGE GPS V06
• 00643169729155: STENT SERB65-12-40-80 PROTEGE GPS V06
• 00643169729148: STENT SERB65-12-40-120 PROTEGE GPS V06
• 00643169729131: STENT SERB65-12-30-80 PROTEGE GPS V06
• 00643169729124: STENT SERB65-12-30-120 PROTEGE GPS V06
• 00643169729117: STENT SERB65-12-20-80 PROTEGE GPS V06
• 00643169729100: STENT SERB65-12-20-120 PROTEGE GPS V06
• 00643169729094: STENT SERB65-10-80-80 PROTEGE GPS V06
• 00643169729087: STENT SERB65-10-80-120 PROTEGE GPS V06
• 00643169729070: STENT SERB65-10-60-80 PROTEGE GPS V06
• 00643169729063: STENT SERB65-10-60-120 PROTEGE GPS V06
• 00643169729056: STENT SERB65-10-40-80 PROTEGE GPS V06
• 00643169729049: STENT SERB65-10-40-120 PROTEGE GPS V06
• 00643169729032: STENT SERB65-10-30-80 PROTEGE GPS V06
• 00643169729025: STENT SERB65-10-30-120 PROTEGE GPS V06
• 00643169729018: STENT SERB65-10-20-80 PROTEGE GPS V06
• 00643169729001: STENT SERB65-10-20-120 PROTEGE GPS V06
• 00643169728998: STENT SERB65-09-80-80 PROTEGE GPS V06
• 00643169728981: STENT SERB65-09-80-120 PROTEGE GPS V06
• 00643169728974: STENT SERB65-09-60-80 PROTEGE GPS V06
• 00643169728967: STENT SERB65-09-60-120 PROTEGE GPS V06
• 00643169728950: STENT SERB65-09-40-80 PROTEGE GPS V06
• 00643169728943: STENT SERB65-09-40-120 PROTEGE GPS V06
• 00643169728936: STENT SERB65-09-30-80 PROTEGE GPS V06
• 00643169728929: STENT SERB65-09-30-120 PROTEGE GPS V06
• 00643169728912: STENT SERB65-09-20-80 PROTEGE GPS V06
• 00643169728905: STENT SERB65-09-20-120 PROTEGE GPS V06
• 00821684071786: STENT SERB65-14-80-80 PROTEGE GPS V05
• 00821684071779: STENT SERB65-14-80-120 PROTEGE GPS V05
• 00821684071762: STENT SERB65-14-60-80 PROTEGE GPS V05
• 00821684071755: STENT SERB65-14-60-120 PROTEGE GPS V05
• 00821684071748: STENT SERB65-14-40-80 PROTEGE GPS V05
• 00821684071731: STENT SERB65-14-40-120 PROTEGE GPS V05
• 00821684071724: STENT SERB65-14-30-80 PROTEGE GPS V05
• 00821684071717: STENT SERB65-14-30-120 PROTEGE GPS V05
• 00821684071700: STENT SERB65-14-20-80 PROTEGE GPS V05
• 00821684071694: STENT SERB65-14-20-120 PROTEGE GPS V05
• 00821684071687: STENT SERB65-12-80-80 PROTEGE GPS V05
• 00821684071670: STENT SERB65-12-80-120 PROTEGE GPS V05
• 00821684071663: STENT SERB65-12-60-80 PROTEGE GPS V05
• 00821684071656: STENT SERB65-12-60-120 PROTEGE GPS V05
• 00821684071649: STENT SERB65-12-40-80 PROTEGE GPS V05
• 00821684071632: STENT SERB65-12-40-120 PROTEGE GPS V05
• 00821684071625: STENT SERB65-12-30-80 PROTEGE GPS V05
• 00821684071618: STENT SERB65-12-30-120 PROTEGE GPS V05
• 00821684071601: STENT SERB65-12-20-80 PROTEGE GPS V05
• 00821684071595: STENT SERB65-12-20-120 PROTEGE GPS V05