Cystoscope

GUDID 04059082029948

SOPRO-COMEG GmbH

Rigid cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope Rigid optical cystoscope

• Primary Device ID: 04059082029948
• NIH Device Record Key: 5fba9f96-4270-4758-8967-365db3f3c56c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cystoscope
• Version Model Number: 165 271 872
• 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	04059082029948 [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

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

Moist Heat or Steam Sterilization

[04059082029948]

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