Protege GPS SERB65-14-20-80

GUDID 00821684031667

Self-Expanding Biliary Stent System

Covidien LP

Bare-metal biliary stent

• Primary Device ID: 00821684031667
• NIH Device Record Key: 35f54967-e1f2-46bd-85ce-9ab38024fa1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protege GPS
• Version Model Number: SERB65-14-20-80
• Catalog Number: SERB65-14-20-80
• 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
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.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
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 14 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0

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	00821684031667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050725

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: 2015-10-23

On-Brand Devices [Protege GPS]

• 00821684031841: Self-Expanding Biliary Stent System
• 00821684031834: Self-Expanding Biliary Stent System
• 00821684031827: Self-Expanding Biliary Stent System
• 00821684031810: Self-Expanding Biliary Stent System
• 00821684031803: Self-Expanding Biliary Stent System
• 00821684031797: Self-Expanding Biliary Stent System
• 00821684031780: Self-Expanding Biliary Stent System
• 00821684031773: Self-Expanding Biliary Stent System
• 00821684031766: Self-Expanding Biliary Stent System
• 00821684031759: Self-Expanding Biliary Stent System
• 00821684031742: Self-Expanding Biliary Stent System
• 00821684031735: Self-Expanding Biliary Stent System
• 00821684031728: Self-Expanding Biliary Stent System
• 00821684031711: Self-Expanding Biliary Stent System
• 00821684031704: Self-Expanding Biliary Stent System
• 00821684031698: Self-Expanding Biliary Stent System
• 00821684031681: Self-Expanding Biliary Stent System
• 00821684031674: Self-Expanding Biliary Stent System
• 00821684031667: Self-Expanding Biliary Stent System
• 00821684031650: Self-Expanding Biliary Stent System
• 00821684003169: Self-Expanding Biliary Stent System
• 00821684003152: Self-Expanding Biliary Stent System
• 00821684003145: Self-Expanding Biliary Stent System
• 00821684003138: Self-Expanding Biliary Stent System
• 00821684003121: Self-Expanding Biliary Stent System
• 00821684002988: Self-Expanding Biliary Stent System
• 00821684002971: Self-Expanding Biliary Stent System
• 00821684002964: Self-Expanding Biliary Stent System
• 00821684002957: Self-Expanding Biliary Stent System
• 00821684002940: Self-Expanding Biliary Stent System
• 00821684002926: Self-Expanding Biliary Stent System
• 00821684002919: Self-Expanding Biliary Stent System
• 00821684002902: Self-Expanding Biliary Stent System
• 00821684002896: Self-Expanding Biliary Stent System
• 00821684002889: Self-Expanding Biliary Stent System
• 00821684002865: Self-Expanding Biliary Stent System
• 00821684002858: Self-Expanding Biliary Stent System
• 00821684002841: Self-Expanding Biliary Stent System
• 00821684002834: Self-Expanding Biliary Stent System
• 00821684002827: Self-Expanding Biliary Stent System
• 00821684002803: Self-Expanding Biliary Stent System
• 00821684002797: Self-Expanding Biliary Stent System
• 00821684002780: Self-Expanding Biliary Stent System
• 00821684002773: Self-Expanding Biliary Stent System
• 00821684002766: Self-Expanding Biliary Stent System
• 00821684002742: Self-Expanding Biliary Stent System
• 00821684002735: Self-Expanding Biliary Stent System
• 00821684002728: Self-Expanding Biliary Stent System
• 00821684002711: Self-Expanding Biliary Stent System
• 00821684002704: Self-Expanding Biliary Stent System