EzRay Air W - VEX-S300W X-RAY SYSTEM(900MM)(R5)/(EzRay Air - VATECH CO., LTD.

Duns Number:689229516

Device Description: VEX-S300W X-RAY SYSTEM(900MM)(R5)/(EzRay Air W)(US)

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More Product Details

Catalog Number

-

Brand Name

EzRay Air W

Version/Model Number

VEX-S300W

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

K163705

Product Code Details

Product Code

EHD

Product Code Name

Unit, X-Ray, Extraoral With Timer

Device Record Status

Public Device Record Key

39897cad-e55a-4dbe-b738-692ab22a8a41

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

March 25, 2019

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