Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

ADVH093_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

DXZ

Product Code Name

PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Public Device Record Key

af655d8b-a8c8-494e-8a9f-75014c2e3618

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

20809160032586

Quantity per Package

12

Contains DI Package

10809160032589

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-