X-MIND trium - X-MIND trium PAN CBCT CEPH version including one - DE GOTZEN SRL

Duns Number:433051802

Device Description: X-MIND trium PAN CBCT CEPH version including one PAN sensor, with control panel on the ri X-MIND trium PAN CBCT CEPH version including one PAN sensor, with control panel on the right side including one removable ceph sensor ceph arm on the left

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More Product Details

Catalog Number

W0900006

Brand Name

X-MIND trium

Version/Model Number

XMT PAN 3D R CEPH L

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 15, 2016

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

K160166

Product Code Details

Product Code

MUH

Product Code Name

System,X-Ray,Extraoral Source,Digital

Device Record Status

Public Device Record Key

f78a7788-2d47-475e-96a3-07d5f0755773

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 15, 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