Catalog Number

69180-2A-USA

Brand Name

Model 69180-2A

Version/Model Number

Model 69180-2A

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181456

Product Code

FLE

Product Code Name

Sterilizer, Steam

Public Device Record Key

fc97fe79-3a42-4bdd-8eff-78aad06e1439

Public Version Date

January 13, 2020

Public Version Number

1

DI Record Publish Date

January 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-