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
• 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

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

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

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

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• 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