Almore Microfil Instrument - Gold

Basic Information

• Brand Name: Almore Microfil Instrument - Gold
• Primary DI: 00014081960412
• Version / Model: 96041
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-14
• Public Version: 2
• Public Version Date: 2023-09-08
• Public Version Status: Update
• Public Device Record Key: ed8b4b9a-a615-4c0a-9e5d-655da9f03bc9
• Distribution End Date: 2023-08-01

Device Description

Dental composite instrument, aids in gingival line restoration to shape the margin, Length 6-1/2"

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
Direct Marking	D2489604113	HIBCC
Primary	00014081960412	GS1

Customer Contacts

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