Catalog Number

N5921

Brand Name

Power Dental U.S.A., Inc.

Version/Model Number

N5921

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

LRW

Product Code Name

SCISSORS, GENERAL, SURGICAL

Public Device Record Key

5c872e81-22ab-4dfc-a07a-9849a89f4342

Public Version Date

June 28, 2021

Public Version Number

1

DI Record Publish Date

June 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-