Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

RMRI100_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

K810921,K810921

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

9e4ee1d0-d06d-49f7-94ab-81f620331c2c

Public Version Date

August 09, 2018

Public Version Number

4

DI Record Publish Date

October 31, 2017

Package DI Number

20809160168841

Quantity per Package

30

Contains DI Package

10809160168844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-