Catalog Number

-

Brand Name

SoftPathDx

Version/Model Number

4.1.11.17

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JQP

Product Code Name

Calculator/Data Processing Module, For Clinical Use

Public Device Record Key

7c2a8e2c-614f-40a7-bc86-7be84d0e2b33

Public Version Date

September 14, 2020

Public Version Number

1

DI Record Publish Date

September 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-