MIRACASTSET OF 2 MODEL FORMER-LOWER

Basic Information

• Brand Name: MIRACASTSET OF 2 MODEL FORMER-LOWER
• Primary DI: D2482030671
• Version / Model: 203067
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2023-05-12
• Public Version: 2
• Public Version Date: 2023-07-18
• Public Version Status: Update
• Public Device Record Key: d710b5eb-fbca-4ad1-9288-99967fde236d

Device Description

Dental lab model former

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
EBH	MATERIAL, IMPRESSION TRAY, RESIN	Dental	872.3670	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64556	Custom-made dental anatomy model	A dental device made of gypsum (e.g., plaster, dental stone) intended to be used as a replica (model) of a specific patient’s teeth and gums, to assist with a dental treatment-related procedure (e.g., production of a dental restoration, design of a teeth whitening tray). It is created via casting (i.e., taking the impression of the patient’s teeth/gums, pouring plaster into the impression, and then removing the impression). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D2482030671	HIBCC
Unit of Use	D2482030670	HIBCC

Customer Contacts

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