Endosee

GUDID 60888937013780

Endosee® Dx Cannula with Pipet

Coopersurgical, Inc.

Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope Flexible fibreoptic hysteroscope

• Primary Device ID: 60888937013780
• NIH Device Record Key: bc5ace17-54bc-4cd8-968d-9edf33417567
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endosee
• Version Model Number: ESDX5
• 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	60888937013780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132384

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-29

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