DirectVision

GUDID 10855308006011

18 Fr. Coude tip Foley catheter for DirectVision System

PERCUVISION LLC

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• Primary Device ID: 10855308006011
• NIH Device Record Key: 3bcd90b7-3378-4944-97b7-9dbbf07b03d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DirectVision
• Version Model Number: MA100180
• Company DUNS: 015755434
• Company Name: PERCUVISION LLC
• 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: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855308006014 [Primary]
GS1	10855308006011 [Package]; Contains: 00855308006014; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110214

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

[10855308006011]

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Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-07-12
• Device Publish Date: 2016-09-23

On-Brand Devices [DirectVision]

• 10855308006042: DirectVision Catheterization Kit
• 00855308006038: DirectVision Visual Guide
• 00855308006021: DirectVision Slimline System
• 10855308006011: 18 Fr. Coude tip Foley catheter for DirectVision System
• 10855308006004: 14 Fr. Coude tip catheter for DirectVision system