Catalog Number

-

Brand Name

RSDL

Version/Model Number

F5408ENG

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

Product Code

MAC

Product Code Name

Decontamination Kit

Public Device Record Key

03190d92-7296-427f-8b6d-046eacc0911b

Public Version Date

December 10, 2019

Public Version Number

1

DI Record Publish Date

December 02, 2019

Package DI Number

10817129020010

Quantity per Package

50

Contains DI Package

00817129020013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case