Catalog Number

3-TT-FILTRON 1000

Brand Name

Tissu-Trans Filtron

Version/Model Number

Tissu-Trans Filtron 1000cc

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

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Public Device Record Key

438e4a8e-027e-423a-8bc3-aa3af51b28f8

Public Version Date

January 08, 2021

Public Version Number

7

DI Record Publish Date

August 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-