H/S Catheter • 7 French

GUDID 20888937016486

H/S Catheter • 7 French for Hysterosonography and Hysterosalpingography

Coopersurgical, Inc.

Salpingographic catheter

• Primary Device ID: 20888937016486
• NIH Device Record Key: 03b5e4ef-9cee-4286-b472-7c06834a3c93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H/S Catheter • 7 French
• Version Model Number: 61-5007
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20888937016486 [Package]; Contains: 60888937016484; Package: [10 Units]; In Commercial Distribution
GS1	60888937016484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020951

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: 2017-09-07

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