Endosee System

GUDID 00888937022018

Endosee Display Module, Docking Station, power cord, USB cable

Coopersurgical, Inc.

Flexible fibreoptic hysteroscope

• Primary Device ID: 00888937022018
• NIH Device Record Key: 7aa303bd-4b44-4d2e-9cdd-654ee83fb93b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endosee System
• Version Model Number: ES9000
• 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	00888937022018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183020

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: 2019-05-15
• Device Publish Date: 2019-05-07

Devices Manufactured by Coopersurgical, Inc.

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