Cystoscope

GUDID 04059082030012

SOPRO-COMEG GmbH

Rigid cystoscope

• Primary Device ID: 04059082030012
• NIH Device Record Key: b6aea605-1027-4749-9585-18425b05851a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cystoscope
• Version Model Number: 165 403 000
• 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	04059082030012 [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

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

Moist Heat or Steam Sterilization

[04059082030012]

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 [Cystoscope]

• 04059082030043: 165 403 005
• 04059082030036: 165 403 002
• 04059082030029: 165 403 001
• 04059082030012: 165 403 000
• 04059082030005: 165 303 002
• 04059082029993: 165 303 001
• 04059082029986: 165 293 002
• 04059082029979: 165 293 001
• 04059082029962: 165 293 000
• 04059082029955: 165 271 875
• 04059082029948: 165 271 872
• 04059082029931: 165 271 870
• 04059082029924: 165 211 870
• 04059082029917: 161 271 140
• 04059082004211: 165 403 005BC001
• 04059082004198: 165 403 002BC001
• 04059082004174: 165 403 001BC001
• 04059082004150: 165 403 000BC001
• 04059082004143: 165 303 002BC001
• 04059082004136: 165 303 001BC001
• 04059082004112: 165 293 002BC001
• 04059082004105: 165 293 001BC001
• 04059082004082: 165 293 000BC001
• 04059082004068: 165 271 875BC001
• 04059082004044: 165 271 872BC001
• 04059082004020: 165 271 870BC001
• 04059082003993: 165 211 870BC001
• 04059082002774: 161 271 140BC001