CODMAN® HAKIM® BACTISEAL® NS5048
GUDID 10381780537090
CODMAN® HAKIM® BACTISEAL® Shunt System Clear with Barium Stripe 15cm Ventricular Catheter with Centimeter Markings MR Conditional Contents: Ventricular Catheter 15cm (1), Right Angle Adapter (1); Additional Contents: Stylet (1)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Intracerebral infusion/drainage catheter, long-term| Primary Device ID | 10381780537090 |
| NIH Device Record Key | 5cc9cbf0-1215-47ed-ac69-376bd6f0e66b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CODMAN® HAKIM® BACTISEAL® |
| Version Model Number | NS5048 |
| Catalog Number | NS5048 |
| 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 | |
| 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 | |
| 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 |
Device Dimensions
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
| Catheter Length | 15 Centimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| 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 |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780537090 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K233445
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® HAKIM® BACTISEAL®]
| 10381780537144 | CODMAN® HAKIM® BACTISEAL® Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, wi |
| 10381780537090 | CODMAN® HAKIM® BACTISEAL® Shunt System Clear with Barium Stripe 15cm Ventricular Catheter wit |
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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