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. This version includes wall plate

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More Product Details

Catalog Number

W0800152

Brand Name

X-MIND unity

Version/Model Number

XMU TOP 110 SHORT CONE, INTERF WALL PLATE (16” - 40,64cm)

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

ee370fa6-7108-4117-bf27-92e99c0cb342

Public Version Date

September 03, 2018

Public Version Number

1

DI Record Publish Date

August 03, 2018

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