Catalog Number

PPBUSE13CH

Brand Name

HU-FRIEDY

Version/Model Number

PPBUSE13CH

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EMK

Product Code Name

CURETTE, SURGICAL, DENTAL

Public Device Record Key

34762ed9-25b5-4d08-93a1-369d5fff8f32

Public Version Date

January 22, 2021

Public Version Number

2

DI Record Publish Date

August 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-