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 Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter 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