Catalog Number

VARV025-10

Brand Name

AVID TruCustom

Version/Model Number

VARV025-10_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

2bbbf449-2311-4c3f-8c68-1312aa58725d

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

November 27, 2017

Package DI Number

20809160171049

Quantity per Package

3

Contains DI Package

10809160171042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-