AccessGUDID - DEVICE: AVRA WIRELESS TABLET DISPLAY (00842430111266)

GUDID

Device Identifier (DI) Information

Brand Name: AVRA WIRELESS TABLET DISPLAY
Version or Model: 2872-40
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2872-40
Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.

Primary DI Number: 00842430111266
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084527241 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	No
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?
65166	Operating table patient pressure distribution monitor	An electronic device designed to continuously measure and display a patient’s body pressure distribution on a pressure-sensing operating table mattress during a surgical procedure. It is typically in the form of a portable tablet with dedicated software which wirelessly receives data from the pressure-sensing mattress or a data recording hub.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFC	System, Pressure Measurement, Intermittent

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 75 and 105 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 366e0ecd-00af-428f-b3f6-c85b61e8e1af
Public Version Date: July 15, 2021
Public Version Number: 2
DI Record Publish Date: June 14, 2021