Catalog Number

Not Applicable

Brand Name

Elite Shears

Version/Model Number

ELITE-SH001B

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

-

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

JOK

Product Code Name

Scissors, Medical, Disposable

Public Device Record Key

6faef664-3bfb-4ccc-b9d3-a940e849a720

Public Version Date

April 30, 2021

Public Version Number

1

DI Record Publish Date

April 22, 2021

Package DI Number

00816703023327

Quantity per Package

200

Contains DI Package

00816703023310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case