Catalog Number

61447

Brand Name

AVANOS

Version/Model Number

92791

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"

Yes

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

LRO

Product Code Name

General surgery tray

Public Device Record Key

d087a3a5-63fa-4ff9-a2e1-612bc3b6bb05

Public Version Date

December 13, 2021

Public Version Number

3

DI Record Publish Date

April 26, 2020

Package DI Number

10350770927913

Quantity per Package

4

Contains DI Package

00350770927916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS