Integra DP Valve System 902113

GUDID 10381780033424

Integra DP Valve System is an implantable device which serves as a parallel flow pathway to divert cerebrospinal fluid (CSF) from the cerebral ventricles to an appropriate drainage site (differential pressure valve). It provides controlled intraventricular pressure and CSF drainage in patients with hydrocephalus or other conditions in which CSF flow and/or absorption is impaired. The very low pressure valve (blue band) is used for postoperative drainage of hygromas and other extraventricular conditions.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Ventriculo-peritoneal/atrial shunt

• Primary Device ID: 10381780033424
• NIH Device Record Key: 6a17e3c1-95ab-4e9d-9344-e5bc87fc7e46
• Commercial Distribution Discontinuation: 2018-07-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra DP Valve System
• Version Model Number: 902113
• Catalog Number: 902113
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780033424 [Primary]
HIBCC	M2729021131 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152897

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: 2021-04-07
• Device Publish Date: 2015-10-01

On-Brand Devices [Integra DP Valve System]

• 10381780035657: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033608: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033592: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033585: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033578: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033561: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033554: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033547: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033509: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033493: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033486: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033479: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033462: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033455: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033448: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033431: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033424: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033417: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033400: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033394: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033295: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033288: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033271: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033264: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033257: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033240: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033233: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033226: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033219: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033196: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033189: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033165: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• 10381780033158: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
• M2729MD21021: Fixed-in Subcutaneous Tube Passer for Valve Tunnelization.
• M2729MD21011: Subcutaneous Tube Passer for Valve Tunnelization.