Catalog Number

N4406N

Brand Name

Power Dental U.S.A., Inc.

Version/Model Number

N4406N

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"

Yes

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

EMH

Product Code Name

FORCEPS, RONGEUR, SURGICAL

Public Device Record Key

693ce644-bb46-481b-9eb3-f2a9c1120304

Public Version Date

July 21, 2021

Public Version Number

1

DI Record Publish Date

July 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-