Uterobrush

Basic Information

• Brand Name: Uterobrush
• Primary DI: 00888937003291
• Version / Model: E0001
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 5
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: 0d10228d-cbc7-437e-9d15-1179f18b4957

Device Description

Endometrial brush

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
HFE	Brush, Endometrial	Obstetrics/Gynecology	884.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32634	Endometrial cytology brush	A device with bristle-like projections designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its interior surface. It is used in the study of endometrial cytology (cells). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20888937003295	GS1		500	In Commercial Distribution
Primary	00888937003291	GS1

Premarket Submissions

Submission Number	Supplement Number
K897070	000