AccessGUDID - DEVICE: MicroAire® (00847399006363)

GUDID

Device Identifier (DI) Information

Brand Name: MicroAire®
Version or Model: AO-115
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Microaire Surgical Instruments LLC

Primary DI Number: 00847399006363
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: SAGITTAL SAW BLADE, 25mm X 95mm X 1.27mm

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?
43376	Surgical saw blade, sagittal, single-use	A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GES	Blade, Scalpel

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
Width: 25 Millimeter
Length: 95 Millimeter
Device Size Text, specify: Cutting Thickness: 1.27 mm

Device Record Status

Public Device Record Key: 86698eb7-1887-4e03-bc5b-813e148a098d
Public Version Date: January 06, 2022
Public Version Number: 1
DI Record Publish Date: December 29, 2021