Catalog Number

VARV021-15

Brand Name

AVID TruCustom

Version/Model Number

VARV021-15_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

OEZ

Product Code Name

Cardiovascular procedure kit

Public Device Record Key

b9385e2f-d21e-4bb8-9f25-787cc53334f5

Public Version Date

October 06, 2020

Public Version Number

5

DI Record Publish Date

November 27, 2017

Package DI Number

20809160171025

Quantity per Package

2

Contains DI Package

10809160171028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-