Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

AMDS2000_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

-

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

31b6c32b-b90c-41a4-abaf-80908ecf5a41

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

February 02, 2017

Package DI Number

20809160125431

Quantity per Package

100

Contains DI Package

10809160125434

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-