Peritoneal Catheter 9MZ1011

GUDID 10381780035831

The peritoneal catheter is used to drain cerebrospinal fluid from the outlet of the valve unit into the peritoneum. The distal end of the catheter has four staggered rows of 6-mm slits, which are not readily visible. If the distal outlet hole of the catheter becomes obstructed, the slits open for drainage. The slits perform optimally in a saline environment after soaking for 24 hours at 37 degrees Celsius.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Peritoneal/atrial cerebrospinal fluid catheter

• Primary Device ID: 10381780035831
• NIH Device Record Key: 2cb48929-17b9-4f44-9fe0-b12c019006bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peritoneal Catheter
• Version Model Number: 9MZ1011
• Catalog Number: 9MZ1011
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 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	10381780035831 [Primary]
HIBCC	M2729MZ10111 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861377

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: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-10-01

On-Brand Devices [Peritoneal Catheter]

• M2729MZ110N1: The peritoneal catheter is used to drain cerebrospinal fluid from the outlet of the valve unit i
• 10381780037224: The Integra NeuroSciences Peritoneal Catheter is a 91 cm silicone elastomer barium sulfate strip
• 10381780035831: The peritoneal catheter is used to drain cerebrospinal fluid from the outlet of the valve unit i
• 10381780035824: The peritoneal catheter is used to drain cerebrospinal fluid from the outlet of the valve unit i
• 10381780035664: The peritoneal catheter is used to drain cerebrospinal fluid from the outlet of the valve unit i
• 10381780034308: The peritoneal catheter is used to drain cerebrospinal fluid from the outlet of the valve unit i