Catalog Number

573614A

Brand Name

Devon

Version/Model Number

573614A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 11, 2022

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

-

Product Code

KDD

Product Code Name

Kit, surgical instrument, disposable

Public Device Record Key

d143027d-68ee-4c7e-9444-e34df924b503

Public Version Date

February 11, 2022

Public Version Number

4

DI Record Publish Date

June 27, 2018

Package DI Number

10884521202283

Quantity per Package

30

Contains DI Package

10884521741560

Package Discontinue Date

February 11, 2022

Package Status

Not in Commercial Distribution

Package Type

CASE