MIRABRUSH BLUE STRAIGHT

Basic Information

• Brand Name: MIRABRUSH BLUE STRAIGHT
• Primary DI: D2486054311
• Version / Model: 605431
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-08-04
• Public Version: 1
• Public Version Date: 2023-08-14
• Public Version Status: New
• Public Device Record Key: 4737534a-79f1-4cbb-8d3a-96137943d808

Device Description

Dental applicator brush

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
KFX	ASSEMBLY, THIGH/KNEE/SHANK/ANKLE/FOOT, EXTERNAL	Physical Medicine	890.3500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D2486054310	HIBCC
Primary	D2486054311	HIBCC

Customer Contacts

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