Catalog Number

-

Brand Name

MatriXX Resolution

Version/Model Number

E3063300

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K031634,K031634

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

3b5e6cef-85b7-41f0-95c2-5a5e4d84cdf5

Public Version Date

April 15, 2021

Public Version Number

1

DI Record Publish Date

April 07, 2021

Package DI Number

EIBAE30633001

Quantity per Package

1

Contains DI Package

EIBAE30633000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carry Case