Catalog Number

31319604

Brand Name

Devon

Version/Model Number

31319604

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

NAB

Product Code Name

Gauze / sponge,nonresorbable for external use

Public Device Record Key

53060ffc-9055-43bb-b6fa-6ba45b86b25c

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 23, 2018

Package DI Number

20884521077413

Quantity per Package

80

Contains DI Package

10884521077416

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE