Catalog Number

573814

Brand Name

Devon

Version/Model Number

573814

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)

Yes

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Public Device Record Key

ad69efda-1019-44be-b616-9c8940bfbcfd

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

20884521172125

Quantity per Package

4

Contains DI Package

10884521172128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE