Catalog Number

3-TT-MEGA 1500

Brand Name

Tissu-Trans MEGA

Version/Model Number

Tissu-Trans MEGA 1500

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

077c88e4-0a33-48b4-9e23-fc19e6c06a5b

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

-