AccessGUDID - DEVICE: MicroAire® (00847399009449)

GUDID

Device Identifier (DI) Information

Brand Name: MicroAire®
Version or Model: SO-020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Microaire Surgical Instruments LLC

Primary DI Number: 00847399009449
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: AUTOPSY SAW BLADE, 96.5mm X 41.3mm X 1mm

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?
44988	Autopsy saw blade	A metal instrument, usually of a high-grade stainless steel quality, with a serrated edge and designed for attachment to a powered autopsy saw to cut bone and tough tissue in a cadaver. The device is typically circular with cutting teeth around the outer edge. This is a reusable 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: 96.5 Millimeter
Length: 41.3 Millimeter
Device Size Text, specify: Cutting Thickness: 1 mm

Device Record Status

Public Device Record Key: 33d4002c-132e-4c32-a1e1-6124cbc4151f
Public Version Date: January 06, 2022
Public Version Number: 1
DI Record Publish Date: December 29, 2021