Catalog Number

181A469

Brand Name

AVANOS

Version/Model Number

00013

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

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

4ca8c841-8ea9-4c99-a1b9-9a0bd60338f2

Public Version Date

December 13, 2021

Public Version Number

2

DI Record Publish Date

April 10, 2020

Package DI Number

10193493000132

Quantity per Package

20

Contains DI Package

00193493000135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS