Catalog Number

-

Brand Name

RSDL

Version/Model Number

F5402G

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K023969,K023969,K023969

Product Code

MAC

Product Code Name

Decontamination Kit

Public Device Record Key

fbed5dd1-a444-4887-96cf-c9029d525d97

Public Version Date

December 10, 2019

Public Version Number

1

DI Record Publish Date

December 02, 2019

Package DI Number

20817129020000

Quantity per Package

4

Contains DI Package

10817129020003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Overpack