CODMAN® CERTAS® Plus 82-8827PL
GUDID 10381780535867
CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with SIPHONGUARD®, Accessories and Unitised BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, and Information Manual
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Cerebrospinal fluid shunt valve| Primary Device ID | 10381780535867 |
| NIH Device Record Key | 7b48d34a-9352-453b-8f4e-12b9edc8ecfa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CODMAN® CERTAS® Plus |
| Version Model Number | 828827PL |
| Catalog Number | 82-8827PL |
| 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 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| 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 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| 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 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| 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 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| 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 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| 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 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| 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 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| 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 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| 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 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| 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 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| 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 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780529293 [Previous] |
| GS1 | 10381780535867 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223330
FDA Product Code
| HCA | CATHETER, VENTRICULAR |
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 |
Trademark Results [CODMAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CODMAN 72381672 0917323 Live/Registered |
JOHNSON & JOHNSON 1971-02-18 |
 CODMAN 72381347 0925169 Live/Registered |
JOHNSON & JOHNSON 1971-02-11 |
 CODMAN 72258343 0840934 Live/Registered |
CODMAN & SHURTLEFF, INC. 1966-11-10 |
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