ALGERBRUSH CORNEAL RUST RING REMOVER

Basic Information

• Brand Name: ALGERBRUSH CORNEAL RUST RING REMOVER
• Primary DI: 00192896012615
• Version / Model: 11-4600
• Catalog Number: 11-4600
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-18
• Public Version: 3
• Public Version Date: 2019-05-14
• Public Version Status: Update
• Public Device Record Key: 0aeac0fb-324c-429f-ba29-4f3d7b5de9b2

Device Description

ALGERBRUSH II CORNEAL RUST RING REMOVER BURR BATTERY POWERED

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: 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: 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
16413	Corneal bur, rust ring removal, reusable	A small shaft made of a hard metal (e.g., steel) with fluting or cutting planes designed for gentle removal ("brushing") of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object. It is attached to the tip of a special slow-rotation powered ophthalmic handpiece. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896012615	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.5 Millimeter Burr