Catalog Number

60407

Brand Name

AVANOS

Version/Model Number

92663

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K882199,K882199

Product Code

LYR

Product Code Name

Helicobacter pylori

Public Device Record Key

62669b36-aaef-40d6-962e-54d77ec240d5

Public Version Date

August 01, 2019

Public Version Number

1

DI Record Publish Date

July 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-