Catalog Number

RDLD044-02

Brand Name

AVID TruCustom

Version/Model Number

RDLD044-02_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

OES

Product Code Name

Cardiac catheterization kit

Public Device Record Key

8bb0cc82-1ea2-4a9b-a076-303412be0fb6

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

November 22, 2017

Package DI Number

20809160170882

Quantity per Package

4

Contains DI Package

10809160170885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-