Centurion

Basic Information

• Brand Name: Centurion
• Primary DI: 00653160024166
• Version / Model: 4022
• Catalog Number: 4022
• Company Name: CENTURION MEDICAL PRODUCTS CORPORATION
• Labeler DUNS: 017246562
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-31
• Public Version: 1
• Public Version Date: 2022-01-10
• Public Version Status: New
• Public Device Record Key: 01e2ee79-eda7-4fbe-bab4-08c1b15098be

Device Description

EAR AND ULCER SYRINGE

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
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
Package	50653160024161	GS1	CASE	50	In Commercial Distribution
Primary	00653160024166	GS1

Customer Contacts

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