Catalog Number

MMMN007

Brand Name

AVID TruCustom

Version/Model Number

MMMN007_0013

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

OEZ

Product Code Name

Cardiovascular procedure kit

Public Device Record Key

2be6fae1-7a8d-4e5b-8b65-cdfcd8b4f1d2

Public Version Date

May 30, 2019

Public Version Number

1

DI Record Publish Date

May 22, 2019

Package DI Number

20809160240622

Quantity per Package

3

Contains DI Package

10809160240625

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-