Catalog Number

-

Brand Name

AVID TRUCUSTOM

Version/Model Number

VAMM036

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 03, 2017

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NSB

Product Code Name

Patient personal hygiene kit

Public Device Record Key

e662ef59-68da-4715-b415-5e3d0a9371aa

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 08, 2016

Package DI Number

20809160087920

Quantity per Package

20

Contains DI Package

10809160087923

Package Discontinue Date

April 03, 2017

Package Status

Not in Commercial Distribution

Package Type

-