ALGERBRUSH HANDLE

Basic Information

• Brand Name: ALGERBRUSH HANDLE
• Primary DI: 00192896093805
• Version / Model: 11-4559
• Catalog Number: 11-4559
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-11
• Public Version: 2
• Public Version Date: 2023-07-26
• Public Version Status: Update
• Public Device Record Key: c7d2bc9c-cd1b-4cff-ba2b-3bef8bbce888
• Distribution End Date: 2023-07-25

Device Description

ALGERBRUSH HANDLE

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOG	Burr, Corneal, Battery-Powered	Ophthalmic	886.4070	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42443	Corneal bur system, battery-powered	An assembly of devices designed for abrasion of the cornea and other eye tissues. It typically consists of a small, battery-powered rotatory handpiece with a motor, and a small shaft made of a hard metal such as steel (i.e., a bur) that may include a diamond sphere at its tip. The system is used in procedures such as the gentle removal ("brushing") of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object, abrasion of the cornea to polish corneal scratches or the pterygium bed after surgical removal, and/or abrasion of lid margin lesions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896093805	GS1

Customer Contacts

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