Endosee® Dx Cannula

GUDID 00888937013795

Endosee® Dx Cannula

Coopersurgical, Inc.

Endometrial biopsy kit

• Primary Device ID: 00888937013795
• NIH Device Record Key: a7cb6f47-16ee-4215-87f8-9aef59aeec8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endosee® Dx Cannula
• Version Model Number: ESDX5-SGL
• 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: 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	00888937013795 [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: 2016-12-29

Devices Manufactured by Coopersurgical, Inc.

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