Catalog Number

B89055

Brand Name

Vitruvian Infiltration Pump

Version/Model Number

B89055

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170629

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Public Device Record Key

0f251c9b-388b-4257-9572-54ef6e45a8cd

Public Version Date

August 23, 2018

Public Version Number

4

DI Record Publish Date

July 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-