Catalog Number

P080095

Brand Name

PRO ADVANTAGE

Version/Model Number

P080095

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

LYR

Product Code Name

Helicobacter Pylori

Public Device Record Key

98fc79d1-a33e-46c3-a83f-38438237a20a

Public Version Date

October 24, 2018

Public Version Number

1

DI Record Publish Date

September 23, 2018

Package DI Number

M220P0800955

Quantity per Package

5

Contains DI Package

M220P0800953

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-