WAXING KIT (SET OF 6)

Basic Information

• Brand Name: WAXING KIT (SET OF 6)
• Primary DI: D248304050
• Version / Model: 304050
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-23
• Public Version: 1
• Public Version Date: 2023-03-31
• Public Version Status: New
• Public Device Record Key: 2b2745a2-5d49-4b0e-9472-788e03cea79e

Device Description

WAXING KIT (SET OF 6)

Device Characteristics

• Single Use: No
• 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
EIK	CARVER, WAX, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65077	Dental restoration carver, multiple-material	A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in multiple dental restoration materials such as amalgam, cement, and acrylic or composite resin/plastic (i.e., not dedicated to a particular material) by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It is typically a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D248304050	HIBCC

Customer Contacts

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