Catalog Number

189A034

Brand Name

AVANOS

Version/Model Number

189A034

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OGJ

Product Code Name

Nerve block tray

Public Device Record Key

b6e636ff-579e-4e89-9db9-f1087bf7b963

Public Version Date

June 02, 2022

Public Version Number

1

DI Record Publish Date

May 25, 2022

Package DI Number

10193493000705

Quantity per Package

10

Contains DI Package

00193493000708

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS