Catalog Number

-

Brand Name

Sirona

Version/Model Number

RX93051-000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 10, 2017

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

-

Product Code

MWJ

Product Code Name

Electrocardiograph,Ambulatory(Without Analysis)

Public Device Record Key

51d750b0-bd31-4827-bac2-e1f0a21d2950

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-