X-MIND unity - The X-MIND unity is an X-ray generator for dental - DE GOTZEN SRL

Duns Number:433051802

Device Description: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-MIND unity is anextra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment ofdisease of the teeth, jaw and oral structures.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

W0800014

Brand Name

X-MIND unity

Version/Model Number

XMU BOTTOM 110 LONG CONE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K132378

Product Code Details

Product Code

EHD

Product Code Name

Unit, X-Ray, Extraoral With Timer

Device Record Status

Public Device Record Key

7bc24f27-ee73-492b-a681-41d636e7659c

Public Version Date

August 06, 2018

Public Version Number

4

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DE GOTZEN SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 63