COX BONE DUST COLLECTOR

Basic Information

• Brand Name: COX BONE DUST COLLECTOR
• Primary DI: 00850000126060
• Version / Model: S-3500
• Company Name: Oto-Med, Inc.
• Labeler DUNS: 059817742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 2
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 7486fb60-05f8-456e-ad56-dcc1ec13eb1a

Device Description

COX BONE DUST COLLECTOR

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MXP	Bone Particle Collector	Ear, Nose, Throat	874.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44819	Otological bone particle collector	A filtering device designed to be placed into an otological surgical suction line to collect bone fragments. It consists of a filter within a housing and is intended to save bone particles during the first stage of middle ear surgery for future use. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850000126060	GS1

Customer Contacts

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