Catalog Number

624205

Brand Name

Enhance® Finishing System/Enhance® PoGo® Polishing System

Version/Model Number

624205

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EHJ

Product Code Name

DISK, ABRASIVE

Public Device Record Key

88cb36b7-f11b-4e7a-ab76-a07cf9e1b6ed

Public Version Date

March 23, 2020

Public Version Number

3

DI Record Publish Date

April 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-