CODMAN CERTAS® SIPHONGUARD® BACTISEAL® 82-8817PL
GUDID 10381780529255
Programmable Valve Inline Small Valve with SIPHONGUARD, Accessories and UnitizedCatheter Includes:Ventricular Catheter,Unitized Distal Catheter, Priming Adapter, Right Angle Adapter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Ventriculo-peritoneal/atrial shunt| Primary Device ID | 10381780529255 |
| NIH Device Record Key | 609c7a5d-a93e-4822-9da2-209c8bb4f6a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CODMAN CERTAS® SIPHONGUARD® BACTISEAL® |
| Version Model Number | 828817PL |
| Catalog Number | 82-8817PL |
| 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 | 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(800)654-2873 |
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| Phone | +1(800)654-2873 |
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Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780529255 [Primary] |
| GS1 | 10381780535829 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-04-07 |
| Device Publish Date | 2020-06-02 |
On-Brand Devices [CODMAN CERTAS® SIPHONGUARD® BACTISEAL®]
| 10886704079071 | Programmable Valve Inline Valve with SIPHONGUARD, Accessories and UnitizedCatheter Includes:Vent |
| 10381780529293 | Programmable Valve Right Angle Valve with SIPHONGUARD, Accessories and UnitizedCatheter Includes |
| 10381780529255 | Programmable Valve Inline Small Valve with SIPHONGUARD, Accessories and UnitizedCatheter Include |
Trademark Results [CODMAN CERTAS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CODMAN CERTAS 77852450 4179795 Live/Registered |
INTEGRA LIFESCIENCES CORPORATION 2009-10-20 |
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