Catalog Number

01509012

Brand Name

NA

Version/Model Number

15090-12

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

K082435,K203061

Product Code

FLE

Product Code Name

Sterilizer, steam

Public Device Record Key

54bac932-bcf3-4002-8cc8-1b3bc7497dfd

Public Version Date

November 24, 2020

Public Version Number

3

DI Record Publish Date

August 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-