Catalog Number

TTA2540-1R23MKA

Brand Name

2540MKA

Version/Model Number

2540MKA

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

K833837

Product Code

FLE

Product Code Name

Sterilizer, Steam

Public Device Record Key

81198712-d2b3-453a-884f-f22f640f75d3

Public Version Date

July 29, 2020

Public Version Number

1

DI Record Publish Date

July 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-