Catalog Number

0016164-0002

Brand Name

THALES 3D SCANNER

Version/Model Number

Water Phantom Conv.

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 17, 2021

Issuing Agency

In GS1

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

K200907

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

bffe026e-0dfd-435a-8a6a-8a21946f8540

Public Version Date

September 17, 2021

Public Version Number

2

DI Record Publish Date

July 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-