Catalog Number

60318

Brand Name

AVANOS

Version/Model Number

92660

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

K941464,K941464

Product Code

FDX

Product Code Name

endoscopic cytology brush

Public Device Record Key

8880c635-b56a-454c-ab93-9e2f7287dc4f

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 10, 2019

Package DI Number

10350770926602

Quantity per Package

10

Contains DI Package

00350770926605

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EA