CODMAN® CERTAS® 82-8826PL

GUDID 10381780536109

CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with SIPHONGUARD®, Accessories and Unitized Catheter

Integra LifeSciences Switzerland Sàrl

Cerebrospinal fluid shunt valve

• Primary Device ID: 10381780536109
• NIH Device Record Key: 351a4bc2-0ca2-4d02-9f0a-56f747467edd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN® CERTAS®
• Version Model Number: 828826PL
• Catalog Number: 82-8826PL
• 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	10381780529538 [Previous]
GS1	10381780536109 [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

On-Brand Devices [CODMAN® CERTAS®]

• 10381780536109: CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with SIPHONGUARD®, Accessories and
• 10381780536086: CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with SIPHONGUARD® and Accessories
• 10381780536062: CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve Only with SIPHONGUARD
• 10381780536048: CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with Accessories and Unitized BACTIS
• 10381780536024: CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with Accessories
• 10381780536000: CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve Only
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• 10381780535904: CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve with Accessories
• 10381780535423: CODMAN® CERTAS® Plus Programmable Valve Inline Valve with SIPHONGUARD®, Accessories and Uniti
• 10381780535416: CODMAN® CERTAS® Plus Programmable Valve Inline Valve with SIPHONGUARD® and Accessories
• 10381780535409: CODMAN® CERTAS® Plus Programmable Valve Inline Valve Only with SIPHONGUARD®
• 10381780535386: CODMAN® CERTAS® Plus Programmable Valve Inline Valve with Accessories and Unitized Catheter
• 10381780521051: CODMAN® CERTAS® Plus Programmable Valve Inline Valve with Accessories