OtoClear® Irrigation Tips

Basic Information

• Brand Name: OtoClear® Irrigation Tips
• Primary DI: 00859911004870
• Version / Model: 7200ST
• Catalog Number: 7200ST
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5000
• Record Status: Published
• Publish Date: 2022-01-07
• Public Version: 2
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: 99c3aa5e-d4b3-4db2-a62e-1a8382a22985

Device Description

OtoClear Irrigation Tips, bulk 5,000

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
65187	Ear canal irrigation tip	A small, rigid, funnel-shaped device intended to provide a conduit for irrigation of the ear canal to flush out cerumen (ear wax) in conjunction with a flushing device (e.g., pump, spray bottle, syringe) [not included] during an ear/nose/throat (ENT) procedure; it is not intended for examination, suction or instrument insertion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10859911004877	GS1
Primary	00859911004870	GS1

Customer Contacts

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