Urology Evacuator

GUDID 04059082010939

SOPRO-COMEG GmbH

Suction system bottle

• Primary Device ID: 04059082010939
• NIH Device Record Key: be8ed364-04c3-4f03-bbf0-7c079a3f08f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urology Evacuator
• Version Model Number: 199 090 500BC
• Company DUNS: 507185952
• Company Name: SOPRO-COMEG 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	04059082010939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971881

FDA Product Code

• FJL: RESECTOSCOPE

Sterilization

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

[04059082010939]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [Urology Evacuator]

• 04059082032078: 199 090 500
• 04059082032047: 195 091 500
• 04059082010939: 199 090 500BC
• 04059082009063: 195 091 500 C
• 04059082009001: 195 090 502
• 04059082008998: 195 090 501
• 04059082008981: 195 090 500