Catalog Number

215AC25B130A

Brand Name

XDR

Version/Model Number

Anatomic Sensor, Size 1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K013271

Product Code

MUH

Product Code Name

System,X-Ray,Extraoral Source,Digital

Public Device Record Key

00df7a1e-9441-4b83-9f5a-21705d0d28fe

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-