Nephroscopy guide

GUDID 04059082009650

SOPRO-COMEG GmbH

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 04059082009650
• NIH Device Record Key: a35d7a8b-f04a-46dd-9de7-ef682809183d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nephroscopy guide
• Version Model Number: 195 800 040BC
• 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	04059082009650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945262

FDA Product Code

• FAJ: Cystoscope and accessories, flexible/rigid

Sterilization

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

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

[04059082009650]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-22

On-Brand Devices [Nephroscopy guide]

• 04059082030135: 195 800 040
• 04059082009650: 195 800 040BC