AccessGUDID - DEVICE: Intra Oral Sensor (08809460309850)

GUDID

Device Identifier (DI) Information

Brand Name: Intra Oral Sensor
Version or Model: IOX1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IOX1
Company Name: Dentium Co., Ltd

Primary DI Number: 08809460309850
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 695504638 *Terms of Use

Device Description: Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.

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?
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
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)
MUH	System, X-Ray, Extraoral Source, Digital

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201247	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
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e3f25441-8298-4d9d-b5a3-0c05ed4f86c9
Public Version Date: August 14, 2020
Public Version Number: 1
DI Record Publish Date: August 06, 2020