Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

ONEL028-01_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

NNI

Product Code Name

CONTAINER, SPECIMEN, NON-STERILE

Public Device Record Key

19ebd255-f732-44cb-9044-75e036e2767a

Public Version Date

October 29, 2021

Public Version Number

3

DI Record Publish Date

March 07, 2017

Package DI Number

20809160131630

Quantity per Package

100

Contains DI Package

10809160131633

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-