Endosee

GUDID 00888937022452

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

Coopersurgical, Inc.

Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope Flexible video hysteroscope 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