IntraStent LD Max S18-16

GUDID 00821684014080

Large Diameter Biliary Stent

Covidien LP

Bare-metal biliary stent

• Primary Device ID: 00821684014080
• NIH Device Record Key: edf9b96b-c09e-4860-b845-7ea0618e7da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntraStent LD Max
• Version Model Number: S18-16
• Catalog Number: S18-16
• 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

Device Dimensions

• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 12 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684014080 [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: 2015-10-12

On-Brand Devices [IntraStent LD Max]

• 00821684014219: Large Diameter Peripheral Stent
• 00821684014202: Large Diameter Peripheral Stent
• 00821684014196: Large Diameter Peripheral Stent
• 00821684014189: Large Diameter Peripheral Stent
• 00821684014172: Large Diameter Peripheral Stent
• 00821684014103: Large Diameter Biliary Stent
• 00821684014097: Large Diameter Biliary Stent
• 00821684014080: Large Diameter Biliary Stent