MicroAire®

Basic Information

• Brand Name: MicroAire®
• Primary DI: 00847399000804
• Version / Model: 1100-006
• Company Name: Microaire Surgical Instruments LLC
• Labeler DUNS: 103056420
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-30
• Public Version: 1
• Public Version Date: 2022-01-07
• Public Version Status: New
• Public Device Record Key: ba3652d2-1c8e-41fc-823a-4ef585ed142a

Device Description

BUR GUARD, EXTRA LONG, FOR 1930/5930 INSTRUMENT

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
LXZ	Guard, Instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34004	Surgical instrument guard, reusable	A device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847399000804	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -18 – 49 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 91 Percent (%) Relative Humidity