OtoClear SprayWash System, Single Use Sample

Basic Information

• Brand Name: OtoClear SprayWash System, Single Use Sample
• Primary DI: 00714646000736
• Version / Model: 27291
• Catalog Number: 27291
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-11
• Public Version: 2
• Public Version Date: 2025-09-09
• Public Version Status: Update
• Public Device Record Key: ae4b3d0d-1f06-4a9b-a10b-26c511a128c0
• Distribution End Date: 2025-09-08

Device Description

OtoClear SprayWash System, Single Use Sample

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• 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
LRD	APPLICATOR, ENT DRUG	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62863	Ear canal irrigation kit, reusable	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 manually-operated flushing device (e.g., spray bottle, syringe) and accessory items (e.g., a cup to collect used irrigation solution). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00714646000736	GS1

Customer Contacts

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