MicroAire®

Basic Information

• Brand Name: MicroAire®
• Primary DI: 00847399004994
• Version / Model: 8051-020NS
• Company Name: Microaire Surgical Instruments LLC
• Labeler DUNS: 103056420
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-30
• Public Version: 2
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 88a36ca8-dd50-4afb-b6c2-6e44257dd507
• Distribution End Date: 2022-03-30

Device Description

SST TWIST DRILL, DENTAL, 2mm Dia. x 65mm

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: Yes
• 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
HTW	Bit, Drill	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45697	Fixture/appliance dental drill bit, single-use	A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847399004994	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	2	Millimeter
Length	65	Millimeter