SLIDING RIGISTER CUPULE 20 mm

Basic Information

• Brand Name: SLIDING RIGISTER CUPULE 20 mm
• Primary DI: 03700111401136
• Version / Model: SLIDING RIGISTER CUPULE 20 mm
• Catalog Number: 1404020
• Company Name: LABORATOIRE CCD
• Labeler DUNS: 381633924
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-27
• Public Version: 1
• Public Version Date: 2025-12-05
• Public Version Status: New
• Public Device Record Key: d771c502-598f-4f62-9885-e2ac45c6003e

Device Description

Device for hysterosalpingography and chromopertubation

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	884.1700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60880	Intrauterine imaging medium catheterization kit	A collection of sterile devices intended for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It includes an intrauterine imaging medium catheter, devices dedicated to catheter function (e.g., stylet, syringe), and non-dedicated supportive devices (e.g., drape, cervical dialator, gauze pad, swab sticks). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700111401136	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K894259	000