DirectVision

GUDID 10855308006042

DirectVision Catheterization Kit

PERCUVISION LLC

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• Primary Device ID: 10855308006042
• NIH Device Record Key: 0cba592d-8f75-47d7-9aed-2bcb3b919fc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DirectVision
• Version Model Number: MA100143
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855308006045 [Primary]
GS1	10855308006042 [Package]; Contains: 00855308006045; Package: Case [10 Units]; In Commercial Distribution

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• 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