Catalog Number

69396

Brand Name

AVANOS

Version/Model Number

92811

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

K892218,K892218

Product Code

MNL

Product Code Name

ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Public Device Record Key

4ceefcc8-02e3-498a-9836-72a76f5a1964

Public Version Date

February 04, 2020

Public Version Number

2

DI Record Publish Date

June 21, 2019

Package DI Number

10350770928118

Quantity per Package

24

Contains DI Package

00350770928111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-