Catalog Number

-

Brand Name

Kosmos UP

Version/Model Number

P006598

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

LMD

Product Code Name

System, Digital Image Communications, Radiological

Public Device Record Key

6b911031-45ef-4e11-9315-f7a0fadda42a

Public Version Date

February 16, 2022

Public Version Number

1

DI Record Publish Date

February 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-