Kevor-Curette

Basic Information

• Brand Name: Kevor-Curette
• Primary DI: 00888937003253
• Version / Model: 66-448B
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 5
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: 9a8dff28-2c36-4443-b744-18902cf44229

Device Description

Disposable Endocervical Curette

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: 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
PCF	Sampler, Endocervical	Obstetrics/Gynecology	884.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16227	Endocervical aspirator	A collection of devices designed to remove superficial tissue from the mucous membrane lining the cervical canal (endometrium) through manually-powered suction. It typically includes a slender endocervical curette, a syringe, a bulb, and a pipette. The device is used in obstetrics, gynaecology, surgery, oncology, histology, fertility studies, and cancer screening (cervical carcinoma); it is also used after colposcopy and to aid fertility by removing the mucus plug from the cervix.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20888937003257	GS1		25	In Commercial Distribution
Primary	00888937003253	GS1

Premarket Submissions

Submission Number	Supplement Number
K882404	000