Protege RX SECX-8-20-135

GUDID 00821684038512

Carotid Stent System

Covidien LP

Bare-metal carotid artery stent

• Primary Device ID: 00821684038512
• NIH Device Record Key: a6e37db9-a240-41f5-87f9-348a899fd96b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protege RX
• Version Model Number: SECX-8-20-135
• Catalog Number: SECX-8-20-135
• Company DUNS: 968903703
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
• 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

• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 20 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
• 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
• 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
• 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	00821684038512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060001

FDA Product Code

• NIM: STENT, CAROTID

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: 2014-09-22

On-Brand Devices [Protege RX]

• 00821684038680: Carotid Stent System
• 00821684038673: Carotid Stent System
• 00821684038666: Carotid Stent System
• 00821684038659: Carotid Stent System
• 00821684038642: Carotid Stent System
• 00821684038635: Carotid Stent System
• 00821684038628: Carotid Stent System
• 00821684038611: Carotid Stent System
• 00821684038604: Carotid Stent System
• 00821684038598: Carotid Stent System
• 00821684038581: Carotid Stent System
• 00821684038574: Carotid Stent System
• 00821684038567: Carotid Stent System
• 00821684038550: Carotid Stent System
• 00821684038543: Carotid Stent System
• 00821684038536: Carotid Stent System
• 00821684038529: Carotid Stent System
• 00821684038512: Carotid Stent System
• 00821684038505: Carotid Stent System
• 00821684038499: Carotid Stent System
• 00821684032220: Self-Expanding Biliary Stent System