Catalog Number

NAFB051-02

Brand Name

AVID TruCustom

Version/Model Number

NAFB051-02_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

OES

Product Code Name

Cardiac catheterization kit

Public Device Record Key

38ac8fbd-dc0e-4385-b502-0c388b1d96b8

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

November 21, 2017

Package DI Number

20809160170820

Quantity per Package

8

Contains DI Package

10809160170823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-