Catalog Number

-

Brand Name

ADVANTAGE PLUS Non-Sterile Cotton-Filled Sponges Exodontia

Version/Model Number

ENACC

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

EFN

Product Code Name

COTTON, ROLL

Public Device Record Key

91632f8f-5f10-48c8-a71f-f326182941f7

Public Version Date

September 02, 2022

Public Version Number

1

DI Record Publish Date

August 25, 2022

Package DI Number

50732224001369

Quantity per Package

4

Contains DI Package

30732224001365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-