Endosee Cystoscopy Kit

GUDID 60888937022485

Cystoscopy kit, flexible cystoscopy cannula and sterile drape, 10 of each

Coopersurgical, Inc.

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• Primary Device ID: 60888937022485
• NIH Device Record Key: 4784c73e-8541-4ce4-b8ba-7b1e75fa1642
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endosee Cystoscopy Kit
• Version Model Number: OR-ESCX10KIT
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60888937022485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170660

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-11-09

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