Hartzell Instruments

Basic Information

• Brand Name: Hartzell Instruments
• Primary DI: D813HZM51
• Version / Model: HZM5
• Catalog Number: HZM5
• Company Name: DEN-MAT HOLDINGS, LLC
• Labeler DUNS: 809857704
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2018-08-15
• Public Version: 2
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: 16bd4804-4f98-48f1-af00-1795399c4b2e

Device Description

#M5 C.S. MIRROR - 1 DOZEN

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: Yes
• 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
EAX	Mirror, Mouth	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35812	Dental surgical probe, reusable	A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D813HZM51	HIBCC
Unit of Use	D813HZM50	HIBCC

Customer Contacts

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