Catalog Number

RMRI014-29

Brand Name

AVID TruCustom

Version/Model Number

RMRI014-29_0002

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

-

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

28989571-9776-4b58-a6d3-8d15dc1c4d02

Public Version Date

September 14, 2018

Public Version Number

3

DI Record Publish Date

November 27, 2017

Package DI Number

20809160170943

Quantity per Package

2

Contains DI Package

10809160170946

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-