Catalog Number

N8001S

Brand Name

Power Dental U.S.A., Inc.

Version/Model Number

N8001S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 17, 2022

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

e7131c99-b9dd-4277-b96f-af4c6ca8a4e5

Public Version Date

June 21, 2022

Public Version Number

2

DI Record Publish Date

July 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-