MicroAire®

Basic Information

• Brand Name: MicroAire®
• Primary DI: 00847399016041
• Version / Model: 85061
• Company Name: Microaire Surgical Instruments LLC
• Labeler DUNS: 103056420
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-25
• Public Version: 1
• Public Version Date: 2021-11-02
• Public Version Status: New
• Public Device Record Key: f12a9cd0-4372-44b2-8f30-208e1d170aae

Device Description

Co-Equal to Onyx Blade, SmartRelease

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: No
• 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
EMF	Knife, Surgical	General, Plastic Surgery	878.4800	1
HRX	Arthroscope	Orthopedic	888.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65789	Endoscopic soft-tissue release system dilator/gauge	A patient-contact dilating/measuring component of an endoscopic soft-tissue release system intended to be used for minimally-invasive transection of soft connective tissue (e.g., fascia, tendon) under direct vision. It consists of a probe-like device that is connected to a dedicated handpiece (not included) and used to create a channel for the system’s cutting components and/or provide depth measurements for the transection. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847399016041	GS1

Premarket Submissions

Submission Number	Supplement Number
K211297	000