Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

SPON001_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

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

2f3084ae-3d9b-44cc-b9c0-9ebad389dbc4

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

October 31, 2017

Package DI Number

20809160168865

Quantity per Package

25

Contains DI Package

10809160168868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-