Catalog Number

P371015

Brand Name

PRO ADVANTAGE

Version/Model Number

P371015

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KYT

Product Code Name

Light, Examination, Medical, Battery Powered

Public Device Record Key

afb7cac7-57f4-4b4d-ad24-4440c752842b

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 25, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-