Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

WH0021-00_0003

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

FQL

Product Code Name

STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)

Public Device Record Key

f107de74-b447-4229-99bf-156bc9d8fe1e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 07, 2017

Package DI Number

20809160154646

Quantity per Package

50

Contains DI Package

10809160154649

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-