Catalog Number

33737

Brand Name

AVANOS

Version/Model Number

33737

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K052870,K052870,K052870

Product Code

NZP

Product Code Name

sealant, microbial

Public Device Record Key

519a256f-1b4f-4fdf-b169-d0e1f0506a65

Public Version Date

July 24, 2020

Public Version Number

1

DI Record Publish Date

July 16, 2020

Package DI Number

10193494337374

Quantity per Package

10

Contains DI Package

00193494337377

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

DSP