TraumaCath External Ventricular Cattheter Set INS8420

GUDID 10381780023890

The TraumaCath is designed for diverting fluid from the ventricles through a series of drainage holes near the catheter tip. The catheter can be inserted into the ventricular cavity with the stainless steel style. A trocar is supplied with the catheter to facility subcutaneous tunneling away from the burr hole. The external portion of the catheter may be secured to the scalp by the suture collar.

Integra Lifesciences Corporation

Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term

• Primary Device ID: 10381780023890
• NIH Device Record Key: 56ebc229-ebcc-4908-90ab-444349587b72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TraumaCath External Ventricular Cattheter Set
• Version Model Number: INS8420
• Catalog Number: INS8420
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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
• 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
• 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
• 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 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 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	10381780023890 [Primary]
HIBCC	M269INS84201 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K820247

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: 5
• Public Version Date: 2020-09-22
• Device Publish Date: 2015-09-22

Devices Manufactured by Integra Lifesciences Corporation

• 10381780538271 - BUDDE®: 2024-06-14 Integra® ANEURYSM RETRACTOR 5MM X 6 5 LNG
• 10381780542339 - BUDDE®: 2024-06-14 BUDDE® Halo 6” Retractor Arm
• 10381780252498 - Integra®: 2024-06-11 Integra® Hardware Kit for UCHR
• 10381780542308 - Integra® Luminant®: 2024-06-11 Integra® Luminant® Localizer
• 10381780542193 - Hermetic™ II: 2024-06-06 Hermetic™ II External CSF Drainage Management
• 10381780542209 - Hermetic™ II: 2024-06-06 Hermetic™ II External CSF Drainage Management Replacement Collection Bag
• 10381780542230 - MoniTorr™: 2024-06-06 MoniTorr™ ICP External CSF Drainage System Replacement Bag
• M268WRISTFUSESET0 - Integra® Total Wrist Fusion System: 2024-04-05 The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight holes and a straight plate with nin