Catalog Number

3061

Brand Name

Jiffy Polisher

Version/Model Number

3061

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

-

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

EHK

Product Code Name

CUP, PROPHYLAXIS

Public Device Record Key

98d3d17e-3aa8-4cee-ab5c-970d0ec6807c

Public Version Date

March 23, 2020

Public Version Number

4

DI Record Publish Date

February 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-