Catalog Number

12602

Brand Name

AVANOS

Version/Model Number

96896

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

EFW

Product Code Name

TOOTHBRUSH, MANUAL

Public Device Record Key

bb37e8d5-5432-4655-a9aa-ca9b425169af

Public Version Date

June 17, 2020

Public Version Number

1

DI Record Publish Date

June 09, 2020

Package DI Number

10609038968961

Quantity per Package

25

Contains DI Package

00609038968964

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS