Ear Wax Removal Kit 12 Ct. Case

Basic Information

• Brand Name: Ear Wax Removal Kit 12 Ct. Case
• Primary DI: 10714646000672
• Version / Model: 704
• Catalog Number: 704
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2022-10-27
• Public Version: 3
• Public Version Date: 2023-07-17
• Public Version Status: Update
• Public Device Record Key: fb481b45-a8e3-4e65-a1e5-1fdb662384bd

Device Description

Ear Wax Removal Kit 12 Ct. Case

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
OGQ	Ear irrigation kit	General Hospital	880.6960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11371	Ear canal irrigation kit, single-use	A collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manual syringe and other accessory items. 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	00714646000675	GS1
Primary	10714646000672	GS1

Customer Contacts

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