CFM Technologies

Basic Information

• Brand Name: CFM Technologies
• Primary DI: 00850013958092
• Version / Model: CM2 Blue
• Catalog Number: CM2-BL
• Company Name: C F M TECHNOLOGIES INC
• Labeler DUNS: 040748944
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-06
• Public Version: 2
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 5d179429-3c5a-4740-b79f-521ffe042b69

Device Description

Cerumen Management Set with reusable and single-use curettes.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JYG	Curette, Ear	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63876	Endaural surgical curette, single-use	A slender, hand-held, manual surgical instrument designed for procedures during middle ear surgery (e.g., removal of the superior bony rim), and may in addition be used for scraping within the ear canal (e.g., removing wax). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade stainless steel. This is a single-use device.	No	Active
47522	Endaural surgical curette, reusable	A slender, hand-held, manual surgical instrument designed for procedures during middle ear surgery (e.g., removal of the superior bony rim), and may in addition be used for scraping within the ear canal (e.g., removing wax). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade stainless steel. This is a reusable device.	No	Active
45085	ENT diagnostic set	A collection of battery-powered devices intended to be used by a physician to perform an ear/nose/throat (ENT) clinical examination on a patient. The devices are typically enclosed in a dedicated case and may include an ophthalmoscope, an otoscope, a pharyngoscope, a dedicated interchangeable handle that contains the batteries, which may be rechargeable and common to all the examination devices, different attachments (e.g., ear specula, mirrors, tongue depressors), spare parts (e.g., light bulbs), and may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850013958092	GS1

Customer Contacts

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