AccessGUDID - DEVICE: MicroAire® (00847399007537)

GUDID

Device Identifier (DI) Information

Brand Name: MicroAire®
Version or Model: K-65
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Microaire Surgical Instruments LLC

Primary DI Number: 00847399007537
Issuing Agency: GS1
Commercial Distribution End Date: December 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 103056420 *Terms of Use

Device Description: SST BUR, ROUND OTOLOGY, 25 Flutes x 4mm Dia.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43555	Burring power tool attachment	A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFF	Bur, Surgical, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4 Millimeter
Device Size Text, specify: Number of Flutes: 25

Device Record Status

Public Device Record Key: 8c006d88-65c2-4c4f-882f-98c2c2a51173
Public Version Date: January 06, 2022
Public Version Number: 1
DI Record Publish Date: December 29, 2021