Protege EverFlex PRB35-05-080-080

GUDID 00821684033739

Self-Expanding Biliary Stent System

Covidien LP

Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent

• Primary Device ID: 00821684033739
• NIH Device Record Key: 5bba058f-5ee8-4078-a589-b5e9e9bb9c2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protege EverFlex
• Version Model Number: PRB35-05-080-080
• Catalog Number: PRB35-05-080-080
• 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
• 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

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 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	00821684033739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072301

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: 2015-10-20

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