Cystoscopy adaptor

GUDID 04059082030470

SOPRO-COMEG GmbH

Endoscope assembly adaptor

• Primary Device ID: 04059082030470
• NIH Device Record Key: aa8cf441-08fb-49df-8291-887a738f2984
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cystoscopy adaptor
• Version Model Number: 196 800 150
• 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	04059082030470 [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

[04059082030470]

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 [Cystoscopy adaptor]

• 04059082030654: 198 050 300
• 04059082030647: 198 050 200
• 04059082030630: 198 050 100
• 04059082030500: 196 810 150
• 04059082030494: 196 810 111
• 04059082030470: 196 800 150
• 04059082030319: 196 050 300
• 04059082030302: 196 050 200
• 04059082030296: 196 050 100
• 04059082010588: 198 050 300BC
• 04059082010571: 198 050 200BC
• 04059082010564: 198 050 100BC
• 04059082010397: 196 810 150BC
• 04059082010380: 196 810 111BC
• 04059082010342: 196 800 150BC
• 04059082010144: 196 050 300BC
• 04059082010137: 196 050 200BC
• 04059082010120: 196 050 100BC