AccessGUDID - DEVICE: EzSensor (08800018600023)

GUDID

Device Identifier (DI) Information

Brand Name: EzSensor
Version or Model: EzSensor
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2.0
Company Name: Rayence Co., Ltd.

Primary DI Number: 08800018600023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557804458 *Terms of Use

Device Description: EzSensor is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy. EzSensor is a digital X-ray imaging system designed specifically for dental radiography within the oral cavity. The system captures X-ray images and makes them available for display and storage across your computer network.

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):	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?
44905	Dental digital imaging sensor, intraoral	An analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUH	System,X-Ray,Extraoral Source,Digital

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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 Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Handling Environment Humidity: between 30 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2438838e-c21e-4e82-b180-f68bc50770e6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016