Catalog Number

9519158

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9519158

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)

-

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

7973a297-7530-4977-a58a-4f5c22eb8336

Public Version Date

June 13, 2019

Public Version Number

1

DI Record Publish Date

June 05, 2019

Package DI Number

20889813023901

Quantity per Package

25

Contains DI Package

00889813023907

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-