EarClear Rx

Basic Information

• Brand Name: EarClear Rx
• Primary DI: 00856331006170
• Version / Model: 90001
• Catalog Number: 90001
• Company Name: NUANCE MEDICAL, LLC
• Labeler DUNS: 078797666
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-25
• Public Version: 1
• Public Version Date: 2018-11-26
• Public Version Status: New
• Public Device Record Key: 739587a3-8ff6-4e02-b716-73da9c15daf8

Device Description

EarClear Rx Ear Wash Basin

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
FNY	BASIN, EMESIS	General Hospital	880.6730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35705	Ear bowl	A bowl specifically designed to be used for treatment of the ear(s), e.g., irrigation of the outer ear canal during a ear/nose/throat (ENT) procedure. It is usually constructed to fit the curvature of the head so that it will sit closely under the ear lobe and is typically made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856331006170	GS1

Customer Contacts

• Phone: [phone] ext. 0
• Email: [email protected]