Scanora 6 - PaloDEx Group Oy

Duns Number:459955188

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


More Product Details

Catalog Number

213248

Brand Name

Scanora 6

Version/Model Number

6.x

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

K092591

Product Code Details

Product Code

MUH

Product Code Name

System,X-Ray,Extraoral Source,Digital

Device Record Status

Public Device Record Key

634246d0-78ca-44dc-bc53-703cda1fab78

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PALODEX GROUP OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 93