Catalog Number

-

Brand Name

ILLUMISITE

Version/Model Number

ILS-0900-KT

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"

Yes

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

K191394

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Public Device Record Key

50c083d1-1836-4c92-9d05-94840343b5d7

Public Version Date

October 21, 2022

Public Version Number

4

DI Record Publish Date

October 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-