IntraStent LD Mega S17-16

GUDID 00821684014059

Large Diameter Biliary Stent

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 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 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: 00821684014059
• NIH Device Record Key: 2e16ed27-b81b-4b1c-ba5b-d2a6fad7a139
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntraStent LD Mega
• Version Model Number: S17-16
• Catalog Number: S17-16
• 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
• 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

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• Length: 16 Millimeter
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684014059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020528

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: 2015-10-09

On-Brand Devices [IntraStent LD Mega]

• 00821684014165: Large Diameter Peripheral Stent
• 00821684014073: Large Diameter Biliary Stent
• 00821684014066: Large Diameter Biliary Stent
• 00821684014059: Large Diameter Biliary Stent