OTOCELL® Ear Wick

Basic Information

• Brand Name: OTOCELL® Ear Wick
• Primary DI: EBESEW8240
• Version / Model: EW-824
• Catalog Number: EW-824
• Company Name: Boston Medical Products, Inc.
• Labeler DUNS: 131855157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-20
• Public Version: 3
• Public Version Date: 2022-08-30
• Public Version Status: Update
• Public Device Record Key: f448ab95-1983-479c-b841-47e34c414110

Device Description

Size: 8 x 24 mm

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: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCN	Ear Wick	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33468	Ear wick, non-biodegradable	A non-biodegradable packing material [e.g., loosely twisted unspun cotton, gauze, or polyvinyl alcohol (PVA)] intended to be used in the ear of a patient after internal ear surgery, and/or to administer medicinal substances to the ear to treat ear disorders. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EBESEW8241	HIBCC	Carton	50	In Commercial Distribution
Primary	EBESEW8240	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	24	Millimeter
Outer Diameter	8	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight