Nephroscope

GUDID 04059082030067

SOPRO-COMEG GmbH

Rigid nephroscope

• Primary Device ID: 04059082030067
• NIH Device Record Key: ac977dbd-1796-44fd-af94-6fb8fea57dcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nephroscope
• Version Model Number: 165 800 002
• 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: true
• 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	04059082030067 [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

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

[04059082030067]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-20

On-Brand Devices [Nephroscope]

• 04059082030074: 165 802 630
• 04059082030067: 165 800 002
• 04059082030050: 165 800 000
• 04059082004273: 165 802 630BC001
• 04059082004242: 165 800 002BC001
• 04059082004235: 165 800 000BC001