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 HIBCC

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

b57803ac-f8f1-4054-a9aa-7fa19bc579bd

Public Version Date

October 22, 2018

Public Version Number

2

DI Record Publish Date

September 17, 2018

Package DI Number

H84106752

Quantity per Package

10

Contains DI Package

H84106751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box