NA

Basic Information

• Brand Name: NA
• Primary DI: 04963931071609
• Version / Model: 07160
• Catalog Number: 07160
• Company Name: YDM CORPORATION
• Labeler DUNS: 716059766
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-30
• Public Version: 1
• Public Version Date: 2022-10-10
• Public Version Status: New
• Public Device Record Key: af48f2f3-dbaf-4737-80b9-4ac875c61705

Device Description

A dental instrument used to carve wax patterns, which can be heated for softening the wax while fashioning the pattern.

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
35794	Dental wax carver	A hand-held manual dental instrument used to carve wax patterns with a blunt blade of varying size and shape, which can be heated for softening the wax while fashioning the pattern. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04963931071609	GS1

Customer Contacts

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