Tampa Catheter for Hysterosonography

GUDID 20888937016394

Tampa Catheter for Hysterosonography 5 French • 33 cm Long

Coopersurgical, Inc.

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• Primary Device ID: 20888937016394
• NIH Device Record Key: d79de78a-3ebd-4e44-94d5-717427e552f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tampa Catheter for Hysterosonography
• Version Model Number: 61-2005
• 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	00888937016390 [Primary]
GS1	20888937016394 [Package]; Contains: 00888937016390; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970492

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

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: 2017-10-04

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