Catalog Number

-

Brand Name

Discovery

Version/Model Number

MI

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

Yes

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

-

FDA Premarket Submission

K161574

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Public Device Record Key

89250495-f71c-489f-9797-ac7c856202b1

Public Version Date

August 19, 2022

Public Version Number

2

DI Record Publish Date

October 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-