Catalog Number

N-81021R

Brand Name

Sm RAPTOR Bur (2) Pkg

Version/Model Number

N-81021R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 2018

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EJL

Product Code Name

BUR, DENTAL

Public Device Record Key

8198df0b-25c2-44c8-b46a-51d2dd57de4a

Public Version Date

March 23, 2020

Public Version Number

3

DI Record Publish Date

November 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-