GyneCath Catheter • 7F

GUDID 30888937016568

GyneCath Catheter • 7F for Hysterosonography and Hysterosalpingography

Coopersurgical, Inc.

Salpingographic catheter

• Primary Device ID: 30888937016568
• NIH Device Record Key: 02dc3c2d-967c-40a5-a58c-120656cc6cd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GyneCath Catheter • 7F
• Version Model Number: 19611
• 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	00888937016567 [Primary]
GS1	20888937016561 [Package]; Contains: 00888937016567; Package: [10 Units]; In Commercial Distribution
GS1	30888937016568 [Package]; Contains: 20888937016561; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961752

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-22

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