AccessGUDID - DEVICE: PAD, SENSOR, SET, 3 IN, SKYTRON 6000 (00842430110573)

GUDID

Device Identifier (DI) Information

Brand Name: PAD, SENSOR, SET, 3 IN, SKYTRON 6000
Version or Model: 69413AVS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 69413AVS
Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.

Primary DI Number: 00842430110573
Issuing Agency: GS1
Commercial Distribution End Date: January 26, 2024
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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
65164	Operating table mattress, pressure-sensing	An electrically-powered cushioned mattress with pressure-sensing properties designed to be placed on top of an operating table to serve as the surface upon which the patient is placed, and to map the patient’s body pressure distribution on its surface during a surgical procedure; the gathered data is transmitted to a pressure monitoring hub/tablet for analysis and display. The device is constructed with a pressure-sensitive fabric and is available in pads of different lengths. This is a reusable device.	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 Atmospheric Pressure: between 75 and 105 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 122 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0cfa6610-c1a0-4850-80a2-32a842d58966
Public Version Date: February 01, 2024
Public Version Number: 2
DI Record Publish Date: October 22, 2021