Catalog Number

ACE643D3MXSYS

Brand Name

Penumbra System

Version/Model Number

ACE643D3MXSYS-A

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K162901,K113163,K152840,K160449

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Public Device Record Key

0cbfaaad-99c7-48aa-80c6-ce9ca2bd12b0

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

January 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-