DirectVision

GUDID 00855308006038

DirectVision Visual Guide

PERCUVISION LLC

Flexible video cystoscope, reusable

• Primary Device ID: 00855308006038
• NIH Device Record Key: 76216d79-a789-42b1-a2cc-63ba0b657ece
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DirectVision
• Version Model Number: MA100059
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855308006038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091600

FDA Product Code

• FGC: Urethroscope

Sterilization

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

[00855308006038]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• 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