Catalog Number

SR4426324021

Brand Name

AMSCO

Version/Model Number

AMSCO 400 Steam Sterilizer

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

K112055

Product Code

FLE

Product Code Name

Sterilizer, steam

Public Device Record Key

630dd44f-52d6-4c44-bd61-2737bde324b9

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-