Catalog Number

8MLPUTHPAAAA

Brand Name

Getinge 800 Series

Version/Model Number

833HC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122625

Product Code

FLE

Product Code Name

Sterilizer, Steam

Public Device Record Key

4e782844-7dce-4c68-a0fb-319f555792aa

Public Version Date

September 23, 2019

Public Version Number

1

DI Record Publish Date

September 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-