Catalog Number

N-81011R

Brand Name

A1 18-Flute Needle (1) Pkg

Version/Model Number

N-81011R

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

e102bfa3-b865-498a-a330-41a80340a88c

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

-