ORTHOPHOS XG - ORTHOPHOS XG 3D ready - SIRONA Dental Systems GmbH

Duns Number:340306351

Device Description: ORTHOPHOS XG 3D ready

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More Product Details

Catalog Number

-

Brand Name

ORTHOPHOS XG

Version/Model Number

6281252

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 14, 2021

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

-

Product Code Details

Product Code

EHD

Product Code Name

Unit, X-Ray, Extraoral With Timer

Device Record Status

Public Device Record Key

73cb96a3-b1cb-4fad-beff-92c9c3d83e90

Public Version Date

May 17, 2022

Public Version Number

4

DI Record Publish Date

September 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIRONA DENTAL SYSTEMS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 235
2 A medical device with a moderate to high risk that requires special controls. 326