MicroAire®

Basic Information

• Brand Name: MicroAire®
• Primary DI: 00847399009166
• Version / Model: PAL-R404XL
• Company Name: Microaire Surgical Instruments LLC
• Labeler DUNS: 103056420
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-25
• Public Version: 2
• Public Version Date: 2023-10-23
• Public Version Status: Update
• Public Device Record Key: 66218c0c-801a-490b-a0d0-bf2f02389e56

Device Description

4mm MULTI-USE CANNULA, 10mm PORT, 40cm LONG, MERCEDES

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: No
• 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
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	878.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45414	Liposuction system cannula, reusable	A rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847399009166	GS1

Premarket Submissions

Submission Number	Supplement Number
K171286	000

Device Sizes

Type	Value	Unit	Text
Length	40	Centimeter
Outer Diameter	4	Millimeter
Device Size Text, specify			10mm Port Length