Bionix Development Corporation

Basic Information

• Brand Name: Bionix Development Corporation
• Primary DI: 00859911004160
• Version / Model: 7200
• Catalog Number: 7200
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 40
• Record Status: Published
• Publish Date: 2017-01-28
• Public Version: 4
• Public Version Date: 2023-07-18
• Public Version Status: Update
• Public Device Record Key: 3097b3a3-11e7-420e-99a9-250f9b37d666

Device Description

Box of 40 OtoClear Tips

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: Yes
• 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
Primary	00859911004160	GS1
Unit of Use	10859911004167	GS1

Customer Contacts

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