CODMAN® CERTAS® Plus 82-8807PL

GUDID 10381780521280

CODMAN CERTAS® Plus Programmable Valve Inline Valve with SIPHONGUARD®, Accessories and Unitized BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual

INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Cerebrospinal fluid shunt valve

• Primary Device ID: 10381780521280
• NIH Device Record Key: ec625ad2-30d5-452f-8c25-835aaf05a85e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN® CERTAS® Plus
• Version Model Number: 828807PL
• Catalog Number: 82-8807PL
• Company DUNS: 081277700
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• 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: false
• Expiration Date: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged, Keep away from sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged, Keep away from sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged, Keep away from sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged, Keep away from sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged, Keep away from sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged, Keep away from sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged, Keep away from sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged, Keep away from sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged, Keep away from sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged, Keep away from sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780521280 [Previous]
GS1	10381780535430 [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: 2024-11-28
• Device Publish Date: 2024-11-20

On-Brand Devices [CODMAN® CERTAS® Plus]

• 10381780535867: CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with SIPHONGUARD®, Accessories and
• 10381780535843: CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with Accessories and Unitised BACTIS
• 10381780535805: CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve with Accessories and Unitised BACTI
• 10381780521280: CODMAN CERTAS® Plus Programmable Valve Inline Valve with SIPHONGUARD®, Accessories and Unitize