Catalog Number

RMRI062-16AUX

Brand Name

AVID TruCustom

Version/Model Number

RMRI062-16AUX_0001

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

OJK

Product Code Name

Eye tray

Public Device Record Key

7d35c347-547a-4dd9-a05e-eb00e3051390

Public Version Date

September 13, 2018

Public Version Number

3

DI Record Publish Date

September 07, 2017

Package DI Number

20809160161552

Quantity per Package

50

Contains DI Package

10809160161555

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-