Catalog Number

SYN-0866

Brand Name

BrightMatter Plan

Version/Model Number

1.6

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 06, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180394

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

6c5b7a27-7277-420e-a375-4f195b1a9cc9

Public Version Date

August 07, 2019

Public Version Number

4

DI Record Publish Date

September 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-