EarClear Rx

Basic Information

• Brand Name: EarClear Rx
• Primary DI: 00856331006217
• Version / Model: 90006
• Catalog Number: 90006
• 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: 351bac7b-9a0d-4a75-9245-38db1a896e7e

Device Description

EarClear Rx Disposable Tips- 20 pack

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
62866	Slide-mounted-tissue dissection system IVD	An assembly of mains electricity (AC-powered) software-based devices designed to be used in the laboratory for the automated, or remotely-controlled, computer-aided dissection of microscope-slide-mounted tissue specimens under digital image guidance, allowing the user to digitally preselect the target dissection area with high precision. It consists of a high-resolution magnification unit, a robotic arm with an attached disposable milling tip, a remote control unit, and a display screen; excised tissues are suctioned into a sample tube for subsequent histopathology analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856331006217	GS1

Customer Contacts

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