EarClear Rx

Basic Information

• Brand Name: EarClear Rx
• Primary DI: 00856331006200
• Version / Model: 90005
• Catalog Number: 90005
• 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: 3
• Public Version Date: 2020-04-20
• Public Version Status: Update
• Public Device Record Key: 5d5ee5f5-a236-4793-8977-50d59b3c3b8c

Device Description

EarClear Rx Ear Wash System Rigid

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
KCP	SYRINGE, ENT	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62865	Knee femur stem/sleeve connector	A sterile implantable device intended to provide a connection between a knee femur prosthesis and a knee stem or sleeve when the knee femur prosthesis does not have a connection point inherent in its design. It takes various forms including a plate and trunnion, or a cylinder, and is made of metal [e.g., cobalt-chrome (Co-Cr)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856331006200	GS1

Customer Contacts

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