CODMAN® HOLTER® 82-1698

GUDID 10381780540748

CODMAN® HOLTER® Lumbo-Peritoneal Shunt, Hoffman Design 3.6mm

INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Lumboperitoneal shunt

• Primary Device ID: 10381780540748
• NIH Device Record Key: d7cacf4f-be03-41ac-9eca-e10ca539f5b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN® HOLTER®
• Version Model Number: 821698
• Catalog Number: 82-1698
• Company DUNS: 081277700
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780518129 [Previous]
GS1	10381780540748 [Primary]

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: 2024-06-06
• Device Publish Date: 2024-05-29

Devices Manufactured by INTEGRA LIFESCIENCES PRODUCTION CORPORATION

• 10381780524106 - CODMAN® BACTISEAL®: 2024-11-28 CODMAN® BACTISEAL® 1.5mm I.D. EVD Catheter Set MR SAFE Contents: 20cm Ventricular Catheter (1), Connector (1), Cap (1), Cathet
• 10381780525370 - CODMAN® BACTISEAL®: 2024-11-28 CODMAN® BACTISEAL® 1.5mm I.D. EVD Catheter Set MR SAFE Contents: 35cm Ventricular Catheter (1), Connector (1), Cap (1), Cathet
• 10381780521280 - CODMAN® CERTAS® Plus: 2024-11-28 CODMAN CERTAS® Plus Programmable Valve Inline Valve with SIPHONGUARD®, Accessories and Unitized BACTISEAL® Catheter Includes:
• 10381780535805 - CODMAN® CERTAS® Plus: 2024-11-28 CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve with Accessories and Unitised BACTISEAL® Catheter Includes: BACTIS
• 10381780535843 - CODMAN® CERTAS® Plus: 2024-11-28 CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with Accessories and Unitised BACTISEAL® Catheter Includes: BACTISE
• 10381780535867 - CODMAN® CERTAS® Plus: 2024-11-28 CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with SIPHONGUARD®, Accessories and Unitised BACTISEAL® Catheter In
• 10381780536970 - CODMAN® BACTISEAL®: 2024-11-28 CODMAN® BACTISEAL® 1.5mm I.D. EVD Catheter Set MR SAFE Contents: 35cm Ventricular Catheter (1), Connector (1), Cap (1), Cathet
• 10381780536987 - CODMAN® BACTISEAL®: 2024-11-28 CODMAN® BACTISEAL® Ventricular Catheter and Distal Catheter Kit with BACTISEAL Shunt System MR CONDITIONAL contents: Ventricul