Endosee

GUDID 00888937022452

Hysteroscope/Cystoscope, Charging Station, USB cable, and power cord

Coopersurgical, Inc.

Flexible video hysteroscope

• Primary Device ID: 00888937022452
• NIH Device Record Key: 61f8afc0-c03d-4aa7-86ef-ca2b2efa70a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endosee
• Version Model Number: OR-ES8000
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00888937022452 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-10
• Device Publish Date: 2018-11-09

On-Brand Devices [Endosee ]

• 60888937013780: Endosee® Dx Cannula with Pipet
• 00888937022452: Hysteroscope/Cystoscope, Charging Station, USB cable, and power cord
• 00888937013320: Hysteroscope with Charging Station, Power Supply and USB Cable
• 00888937013177: Endosee® Hysteroscope with Charging Station/Power Supply/USB Cable
• 60888937026674: Endosee System Convenience Kit with IV Tube Instrument Tray for Hysteroscopy