AccessGUDID - DEVICE: Eighteeth (06941877815196)

GUDID

Device Identifier (DI) Information

Brand Name: Eighteeth
Version or Model: NanoPix1.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6980098
Company Name: Changzhou Sifary Medical Technology Co., Ltd.

Primary DI Number: 06941877815196
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 560366787 *Terms of Use

Device Description: The NanoPix series sensors (NanoPix1, NanoPix1.5, NanoPix2) are USB-driven digital intraoral sensors based on a CMOS (Complementary Metal Oxide Semiconductor) technology that has been specifically designed for dental applications. The NanoPix series intraoral sensors provide digital diagnostic image capture to replace radiographic film/screen system in general dental diagnostic procedures. The captured digital image is transferred to personal computer via USB port.

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
MUH	System, X-Ray, Extraoral Source, Digital

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220422	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 73d3bc6e-8e4c-403f-b1d1-a39b198c79f5
Public Version Date: January 29, 2025
Public Version Number: 1
DI Record Publish Date: January 21, 2025