N/A

GUDID 04260491620057

Complete System Uroview FD Left Configuration

Pausch Medical GmbH

Stationary uro-gynaecological fluoroscopic x-ray system, digital

• Primary Device ID: 04260491620057
• NIH Device Record Key: 18e06d46-6fe4-4dd0-b5c4-d7d9b1e41d79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 01169034-S
• Company DUNS: 342800789
• Company Name: Pausch Medical GmbH
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260491620040 [Primary]
GS1	04260491620057 [Package]; Contains: 04260491620040; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161019

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-08

On-Brand Devices [N/A]

• 04260491620071: Cosmos 2, DEL - Bucky left
• 04260491620057: Complete System Uroview FD Left Configuration
• 04260491620033: Uroview FD Left Configuration. Part of 01169034-S
• 04260491620019: Complete System Uroview FD Right Configuration
• 04260491620002: Uroview FD Right Configuration. Part of 01169033-S