PaX-i3D Green - Dental Computed Tomography X-ray System - VATECH CO., LTD.

Duns Number:689229516

Device Description: Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisit Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru1215CF / Xmaru2301CF)

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More Product Details

Catalog Number

-

Brand Name

PaX-i3D Green

Version/Model Number

PHT-60CFO

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

-

Product Code Details

Product Code

OAS

Product Code Name

X-Ray, Tomography, Computed, Dental

Device Record Status

Public Device Record Key

f8a266d1-7b98-4b3e-b637-86ff26def986

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VATECH 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. 76