Catalog Number

951

Brand Name

Dale General Purpose Securement Device

Version/Model Number

951

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

3cd24853-7311-4fdd-8341-fe776bb9f621

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

September 10, 2018

Package DI Number

00817612020230

Quantity per Package

50

Contains DI Package

00817612020223

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box