Catalog Number

675

Brand Name

Dale IV Armor

Version/Model Number

675

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)

-

Over the Counter (OTC)

Yes

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

d3c09dad-a44e-4dd5-ad02-976820edbf7b

Public Version Date

May 10, 2021

Public Version Number

3

DI Record Publish Date

February 19, 2019

Package DI Number

00817612020872

Quantity per Package

10

Contains DI Package

00817612020865

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box