Catalog Number

RMRI017-19

Brand Name

AVID TruCustom

Version/Model Number

RMRI017-19_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

OJH

Product Code Name

Orthopedic tray

Public Device Record Key

f727ef44-a403-45af-a68a-b2a20675c5e1

Public Version Date

September 17, 2018

Public Version Number

3

DI Record Publish Date

November 27, 2017

Package DI Number

20809160170950

Quantity per Package

2

Contains DI Package

10809160170953

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-