Catalog Number

12300004Z

Brand Name

3D SCANNER TPR Option

Version/Model Number

12300004Z

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 18, 2019

Issuing Agency

In HIBCC

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

K101992

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

7745924d-bdd5-4773-bd14-7e5cdcbfadd1

Public Version Date

June 18, 2019

Public Version Number

5

DI Record Publish Date

January 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-