Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

RMRI100_0004

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

K810921,K810921

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

d2652157-5ff7-47f3-a619-92f8633e4f1d

Public Version Date

August 09, 2018

Public Version Number

4

DI Record Publish Date

October 31, 2017

Package DI Number

20809160168858

Quantity per Package

30

Contains DI Package

10809160168851

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-