CLAROX - CLAROX is a battery-operated, portable dental - VSI Co., Ltd.

Duns Number:690151865

Device Description: CLAROX is a battery-operated, portable dental X-ray source designed for handheld operation CLAROX is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The CLAROX is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner’s office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow for the use of the CLAROX where transportation or use of other x-ray devices might be prohibitive due to the other device’s size and/or lack of mobility. The CLAROX is an X-ray device with an AC/DC adaptor. The handheld device features a main body (tube head), Cone for sensor, Acryl shielding, cradle, and AC/DC adaptor.

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More Product Details

Catalog Number

VX-30

Brand Name

CLAROX

Version/Model Number

VX-30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K221286,K221286

Product Code Details

Product Code

EHD

Product Code Name

Unit, X-Ray, Extraoral With Timer

Device Record Status

Public Device Record Key

b5d986c9-cd8e-475d-b926-23150e224915

Public Version Date

August 02, 2022

Public Version Number

1

DI Record Publish Date

July 25, 2022

Additional Identifiers

Package DI Number

18800124900007

Quantity per Package

5

Contains DI Package

08800124900000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box

"VSI CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2