Catalog Number

Not Applicable

Brand Name

Elite Triangle Bandage

Version/Model Number

ELITE-TRI40

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"

-

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

ILI

Product Code Name

Sling, Arm

Public Device Record Key

ae6cc828-1b99-47a3-8aa6-6c8c6b1d1608

Public Version Date

April 30, 2021

Public Version Number

1

DI Record Publish Date

April 22, 2021

Package DI Number

00840155407800

Quantity per Package

240

Contains DI Package

00816703023334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case