Catalog Number

MMSY009

Brand Name

AVID TruCustom

Version/Model Number

MMSY009_0004

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

OJG

Product Code Name

Neurological tray

Public Device Record Key

353fe897-a8dd-46ca-aa3d-a05009273ad0

Public Version Date

April 23, 2019

Public Version Number

1

DI Record Publish Date

April 15, 2019

Package DI Number

20809160235840

Quantity per Package

2

Contains DI Package

10809160235843

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-