Catalog Number

5075HSSM-208-MD

Brand Name

5075HSG

Version/Model Number

5075HSG - M

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

K143311

Product Code

FLE

Product Code Name

Sterilizer, Steam

Public Device Record Key

4f080ad8-5ffa-48fb-8dc7-b946ec629516

Public Version Date

October 17, 2018

Public Version Number

1

DI Record Publish Date

September 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-