Catalog Number

GSS67N Model 6713

Brand Name

GETINGE

Version/Model Number

6713

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

K172159

Product Code

FLE

Product Code Name

Sterilizer, Steam

Public Device Record Key

55882c63-7253-4ebf-b3c5-a97a7e3101e0

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-