AccessGUDID - DEVICE: DEXIS Platinum™ intraoral sensor (EKAV101184170)

GUDID

Device Identifier (DI) Information

Brand Name: DEXIS Platinum™ intraoral sensor
Version or Model: 1.011.8417
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PLU5109S
Company Name: DEXIS LLC

Primary DI Number: EKAV101184170
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 019717844 *Terms of Use

Device Description: Digital intraoral sensor

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:	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?
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 [?]
K090458	000

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
Handling Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e6fafdd9-9cad-4946-893c-61bcc5eee58a
Public Version Date: January 31, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016