Catalog Number

USAR019-09

Brand Name

AVID TruCustom

Version/Model Number

USAR019-09_0003

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

728699e0-b99e-4296-8b38-22d8fcb99dda

Public Version Date

September 13, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2017

Package DI Number

20809160163136

Quantity per Package

6

Contains DI Package

10809160163139

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-