Catalog Number

-

Brand Name

Elite

Version/Model Number

EL-DTH

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150125

Product Code

KDD

Product Code Name

Kit, Surgical Instrument, Disposable

Public Device Record Key

3e8ca68e-f19b-4db0-bcf6-5c5267de484e

Public Version Date

May 07, 2020

Public Version Number

4

DI Record Publish Date

February 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-