PaX-i - Digital X-ray Imaging System functioning - VATECH CO., LTD.

Duns Number:689229516

Device Description: Digital X-ray Imaging System functioning Pano/Ceph(one-shot type) Image Acquisition (Xmaru Digital X-ray Imaging System functioning Pano/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / 1210SGA)

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More Product Details

Catalog Number

-

Brand Name

PaX-i

Version/Model Number

PCH-2500

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

MUH

Product Code Name

System,X-Ray,Extraoral Source,Digital

Device Record Status

Public Device Record Key

80981cef-071e-4ac4-bad4-686005376dc4

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