Cystoscopy sheath

GUDID 04059082010328

SOPRO-COMEG GmbH

Endoscope sheath, reusable

• Primary Device ID: 04059082010328
• NIH Device Record Key: 6cc15b52-9385-4b0e-9bf1-5c9856ac3db2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cystoscopy sheath
• Version Model Number: 196 800 100BC
• 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	04059082010328 [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

[04059082010328]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-11
• Device Publish Date: 2016-12-22

On-Brand Devices [Cystoscopy sheath]

• 04059082030579: 198 020 500
• 04059082030562: 198 020 400
• 04059082030555: 198 020 300
• 04059082030548: 198 020 200
• 04059082030531: 198 020 100
• 04059082030487: 196 810 101
• 04059082030456: 196 800 100
• 04059082030432: 196 080 410
• 04059082030425: 196 080 400
• 04059082030418: 196 080 310
• 04059082030401: 196 080 300
• 04059082030395: 196 080 210
• 04059082030388: 196 080 200
• 04059082030371: 196 080 100
• 04059082030364: 196 080 000
• 04059082030227: 196 020 500
• 04059082030210: 196 020 400
• 04059082030203: 196 020 301
• 04059082030197: 196 020 300
• 04059082030180: 196 020 200
• 04059082030173: 196 020 100
• 04059082010502: 198 020 500BC
• 04059082010496: 198 020 400BC
• 04059082010489: 198 020 300BC
• 04059082010472: 198 020 200BC
• 04059082010465: 198 020 100BC
• 04059082010373: 196 810 101BC
• 04059082010328: 196 800 100BC
• 04059082010298: 196 080 410BC
• 04059082010281: 196 080 400BC
• 04059082010274: 196 080 310BC
• 04059082010267: 196 080 300BC
• 04059082010250: 196 080 210BC
• 04059082010243: 196 080 200BC
• 04059082010229: 196 080 100BC
• 04059082010205: 196 080 000BC
• 04059082010052: 196 020 500BC
• 04059082010045: 196 020 400BC
• 04059082010038: 196 020 301BC
• 04059082010021: 196 020 300BC
• 04059082010014: 196 020 200BC
• 04059082010007: 196 020 100BC