GyneCath Catheter • 5F

Basic Information

• Brand Name: GyneCath Catheter • 5F
• Primary DI: 00888937016550
• Version / Model: 19610
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-22
• Public Version: 4
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: c0371261-4bc8-48f8-9b69-bbb464fe8a4b

Device Description

GyneCath Catheter • 5F for Hysterosonography and Hysterosalpingography

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34157	Salpingographic catheter	A flexible, balloon-tipped tube inserted transvaginally and through the uterus for the selective catheterization/cannulation of the fallopian tubes, in order to inject dye or a contrast medium into the tubes for a radiographic procedure; it is usually radiopaque. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30888937016551	GS1		4	In Commercial Distribution
Package	20888937016554	GS1		10	In Commercial Distribution
Primary	00888937016550	GS1

Premarket Submissions

Submission Number	Supplement Number
K961752	000