Burr

Basic Information

• Brand Name: Burr
• Primary DI: 00841668113103
• Version / Model: K2-4912
• Catalog Number: K2-4912
• Company Name: KATENA PRODUCTS, INC.
• Labeler DUNS: 085668598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-14
• Public Version: 2
• Public Version Date: 2022-12-15
• Public Version Status: Update
• Public Device Record Key: d471fc6a-c050-4ced-9818-6e4f8b5862a8

Device Description

PTERYGIUM DRILL MEDIUM DIAMOND BURR

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: 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

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	00841668113103	GS1

Customer Contacts

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