H/S Catheter with Integrated Stylet • 5 French

GUDID 20888937016479

H/S Catheter with Integrated Stylet • 5 French for Hysterosonography and Hysterosalpingography

Coopersurgical, Inc.

Salpingographic catheter

• Primary Device ID: 20888937016479
• NIH Device Record Key: ced4aab4-994e-493f-96b2-bc263700f410
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H/S Catheter with Integrated Stylet • 5 French
• Version Model Number: 61-5005
• 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	20888937016479 [Package]; Contains: 60888937016477; Package: [10 Units]; In Commercial Distribution
GS1	60888937016477 [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

On-Brand Devices [H/S Catheter with Integrated Stylet • 5 French]

• 20888937016479: H/S Catheter with Integrated Stylet • 5 French for Hysterosonography and Hysterosalpingography
• 20888937016400: H/S Catheter with Integrated Stylet • 5 French for Hysterosonography and Hysterosalpingography