Catalog Number

G4-621103

Brand Name

STATCLAVE G4 Chamber Autoclave

Version/Model Number

G4-621103

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

K190062

Product Code

FLE

Product Code Name

Sterilizer, Steam

Public Device Record Key

ea95f2e8-0fd2-4a08-9679-cf1c5250b632

Public Version Date

August 21, 2019

Public Version Number

1

DI Record Publish Date

August 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-