Integral Drainage Set 910412

GUDID 10381780034193

The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector; small diameter drainage inlet tube with attached clamp, check valve, and silicone band; graduated bag with hydrophobic vent filter, drip chamber, suspension string with adjustable clip; large diameter drainage collector; outlet tube with clamp, watertight cap and silicone band); a 360° three-way stopcock Luer-lock connectors; 35 cm radiopaque straight ventricular catheter.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit

• Primary Device ID: 10381780034193
• NIH Device Record Key: d3a1bf3e-fcd7-4169-9661-8d86636c67e9
• Commercial Distribution Discontinuation: 2021-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integral Drainage Set
• Version Model Number: 910412
• Catalog Number: 910412
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• 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: 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780034193 [Primary]
HIBCC	M2729104121 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924600

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: 2023-02-09
• Device Publish Date: 2015-10-01

On-Brand Devices [Integral Drainage Set]

• 10381780034209: The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector; smal
• 10381780034193: The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector; smal
• 30381780034180: The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector; smal
• 30381780034173: Two three-way Stopcock Protection Boxes.