Catalog Number

NAMC426-05

Brand Name

AVID TruCustom

Version/Model Number

NAMC426-05_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

Yes

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

cd42905b-4273-4f78-b037-3811fc5d4471

Public Version Date

October 12, 2018

Public Version Number

1

DI Record Publish Date

September 11, 2018

Package DI Number

20809160208851

Quantity per Package

2

Contains DI Package

10809160208854

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-