Catalog Number

573580

Brand Name

Devon

Version/Model Number

573580

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)

Yes

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

e3d3b8f0-509b-43cb-9100-25fa0c63a1b3

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

June 30, 2018

Package DI Number

10884521512122

Quantity per Package

8

Contains DI Package

20884521512129

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE