Catalog Number

69392

Brand Name

AVANOS

Version/Model Number

92810

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)

Yes

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

K841258,K841258

Product Code

FED

Product Code Name

endoscopic access overtube, gastroenterology-urology

Public Device Record Key

6409a39d-20c8-4ca2-a314-33d4b025dd8f

Public Version Date

July 08, 2021

Public Version Number

3

DI Record Publish Date

June 21, 2019

Package DI Number

10350770928101

Quantity per Package

10

Contains DI Package

00350770928104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-