Catalog Number

AMS11-230-W-T

Brand Name

T-Edge 11

Version/Model Number

AMS11-230-W-T

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

K143311,K213080

Product Code

FLE

Product Code Name

Sterilizer, Steam

Public Device Record Key

ccd86ee2-5d19-4c2e-ae44-e18f307618c9

Public Version Date

January 10, 2022

Public Version Number

2

DI Record Publish Date

June 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-