AccessGUDID - DEVICE: XDR (D787215AC25B130A0)

GUDID

Device Identifier (DI) Information

Brand Name: XDR
Version or Model: Anatomic Sensor, Size 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 215AC25B130A
Company Name: CYBER MEDICAL IMAGING, INC.

Primary DI Number: D787215AC25B130A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 112029934 *Terms of Use

Device Description: Dental digital intraoral sensor, size 1

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 [?]
K013271	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Liquid Chemical

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Same as Handling Conditions
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Height: 5.40 Millimeter
Width: 24.35 Millimeter
Length: 36.73 Millimeter

Device Record Status

Public Device Record Key: 00df7a1e-9441-4b83-9f5a-21705d0d28fe
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 31, 2016