Catalog Number

555012

Brand Name

The Ultimate F & P Kit

Version/Model Number

555012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 18, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EJQ

Product Code Name

WHEEL, POLISHING AGENT

Public Device Record Key

39d61508-e838-4a2f-96d9-d6e4bf9311ea

Public Version Date

August 18, 2021

Public Version Number

3

DI Record Publish Date

February 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-