Catalog Number

181A489

Brand Name

AVANOS

Version/Model Number

181A489

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

7500b8a8-aaef-4293-a5ac-c88cd2b10c93

Public Version Date

June 28, 2022

Public Version Number

2

DI Record Publish Date

January 26, 2022

Package DI Number

10193493000644

Quantity per Package

10

Contains DI Package

00193493000647

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS