Endosee

GUDID 00888937013320

Hysteroscope with Charging Station, Power Supply and USB Cable

Coopersurgical, Inc.

Flexible video hysteroscope

• Primary Device ID: 00888937013320
• NIH Device Record Key: 930de414-5165-42e0-9a1d-6aaf21300032
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endosee
• Version Model Number: 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	00888937013320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123151

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-17

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