Integra® Camino® VTUN-Catheter

GUDID M273VTUNCATHETER0

Integra® Camino® Flex Ventricular Intracranial Pressure Monitoring Catheter

GMS, Gesellschaft für medizinische Sondentechnik mbH

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• Primary Device ID: M273VTUNCATHETER0
• NIH Device Record Key: 35e04aae-926b-461f-ba6a-86c78a6c2d06
• Commercial Distribution Discontinuation: 2019-02-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra® Camino®
• Version Model Number: VTUN-Catheter
• Catalog Number: VTUN-Catheter
• Company DUNS: 315902197
• Company Name: GMS, Gesellschaft für medizinische Sondentechnik mbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• 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

Device Dimensions

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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780041450 [Primary]
HIBCC	M273VTUNCATHETER0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133754

FDA Product Code

• GWM: DEVICE, MONITORING, INTRACRANIAL PRESSURE

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: 2019-04-01
• Device Publish Date: 2015-10-01

On-Brand Devices [Integra® Camino®]

• M273VTUNACCESSORI0: Integra® Camino® Flex Ventricular Intracranial Pressure Monitoring Accessories
• M273VTUNCATHETER0: Integra® Camino® Flex Ventricular Intracranial Pressure Monitoring Catheter
• M273VTUN1: Integra® Camino® Flex Ventricular Intracranial Pressure Monitoring Kit