MicroAire®

Basic Information

• Brand Name: MicroAire®
• Primary DI: 00847399004956
• Version / Model: 8051-013
• 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: 2021-12-29
• Public Version: 2
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: ae8e6615-3b3e-4b77-9ddd-064cf8d2d2d5
• Distribution End Date: 2021-12-30

Device Description

SST TWIST DRILL, DENTAL, 1.3mm Dia. x 49mm

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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	00847399004956	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.3	Millimeter
Length	49	Millimeter