PIPELLE® MARK II

Basic Information

• Brand Name: PIPELLE® MARK II
• Primary DI: 03700111400702
• Version / Model: PIPELLE® MARK II
• Catalog Number: 111020100
• Company Name: LABORATOIRE CCD
• Labeler DUNS: 381633924
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-05
• Public Version: 1
• Public Version Date: 2023-12-13
• Public Version Status: New
• Public Device Record Key: e536e3d2-dee2-418a-95fc-65f3147dc322

Device Description

Device for endometrial sampling

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HHK	CURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES)	Obstetrics/Gynecology	884.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32368	Cervical cytology brush	A device with bristle-like projections designed to obtain a cervical biopsy of a suspicious area or visible exocervical lesions detected during a vaginal examination for the purpose of obtaining a tissue diagnosis from a woman with intraepithelial disease. It is inserted into the vagina and the head of the brush is firmly rotated over the area of interest until is covered with a bloody-mucoid sample. Some types may also have small bristles on a central protrusion that simultaneously enters the endocervical canal. The sample is secured in a cytology fixation solution or smeared onto a microscope slide for a Papanicolaou test (PAP). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03700111425705	GS1	Box	25	In Commercial Distribution
Primary	03700111400702	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Length	23.5	Centimeter
Outer Diameter	0.31	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: -The product must not be used in the event of damaged, or open primary packaging before the medical procedure. -Store away from direct sunlight. -Store in a dry place.