CODMAN® CERTAS® 82-8816PL

GUDID 10381780535980

CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve with SIPHONGUARD® ,Accessories and Unitized Catheter

Integra LifeSciences Switzerland Sàrl

Cerebrospinal fluid shunt valve

• Primary Device ID: 10381780535980
• NIH Device Record Key: 86521c6d-5feb-47c4-8195-c9888a18a5ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN® CERTAS®
• Version Model Number: 828816PL
• Catalog Number: 82-8816PL
• Company DUNS: 480186617
• Company Name: Integra LifeSciences Switzerland Sàrl
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values
• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values
• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values
• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values
• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values
• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values
• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values
• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values
• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values
• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values
• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values
• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values
• Special Storage Condition, Specify: Between 0 and 0 *No Storage/Handling Values

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780529415 [Previous]
GS1	10381780535980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223330

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-08
• Device Publish Date: 2025-06-30

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• 10381780535386: CODMAN® CERTAS® Plus Programmable Valve Inline Valve with Accessories and Unitized Catheter
• 10381780521051: CODMAN® CERTAS® Plus Programmable Valve Inline Valve with Accessories