Catalog Number

N7643

Brand Name

Power Dental U.S.A., Inc.

Version/Model Number

N7643

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Public Device Record Key

e24df945-610a-4f09-a86b-4787e77355c9

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

June 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-