Catalog Number

ROCA004-11

Brand Name

AVID TruCustom

Version/Model Number

ROCA004-11_0006

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 23, 2018

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

437ec05c-1cce-4dad-97e5-9183b5caf943

Public Version Date

September 13, 2018

Public Version Number

4

DI Record Publish Date

September 29, 2017

Package DI Number

20809160164836

Quantity per Package

4

Contains DI Package

10809160164839

Package Discontinue Date

August 23, 2018

Package Status

Not in Commercial Distribution

Package Type

-