Catalog Number

-

Brand Name

SUMMIT MEDICAL

Version/Model Number

3-TT-FILTRON 500

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092482,K092482

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Public Device Record Key

93f5b492-8bbd-44bd-8196-104694415045

Public Version Date

February 14, 2022

Public Version Number

3

DI Record Publish Date

April 20, 2021

Package DI Number

10385640053768

Quantity per Package

1

Contains DI Package

00385640053761

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX