Catalog Number

12243

Brand Name

AVANOS*

Version/Model Number

12243

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KXF

Product Code Name

APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Public Device Record Key

13795ff4-6538-45e6-9ec4-707173654d1f

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 19, 2020

Package DI Number

20609038968722

Quantity per Package

25

Contains DI Package

10609038968725

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS