Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

PC01316_0005

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

K971281,K971281

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

a3f060e6-4736-451c-8694-60813b3c6837

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

September 15, 2016

Package DI Number

20809160067458

Quantity per Package

25

Contains DI Package

10809160067451

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-