Catalog Number

-

Brand Name

MediMatic

Version/Model Number

ComPACS

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K041581

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

fa6b128a-ae2e-4472-9c5d-a6ea52b21362

Public Version Date

September 24, 2018

Public Version Number

4

DI Record Publish Date

October 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-