Catalog Number

Not Applicable

Brand Name

Elite Self-Adherent Wrap

Version/Model Number

ELITE-17104

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)

-

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

97ed925f-08dc-46bc-9a47-23dee1fb09ac

Public Version Date

April 27, 2021

Public Version Number

1

DI Record Publish Date

April 19, 2021

Package DI Number

00816703023075

Quantity per Package

12

Contains DI Package

00816703023068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case