Catalog Number

BP04

Brand Name

Dentapen Battery

Version/Model Number

Dentapen for Dentapen

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"

-

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

EJI

Product Code Name

Syringe, Cartridge

Public Device Record Key

5fd30ef5-632b-4739-92f7-55307466fa2e

Public Version Date

November 22, 2018

Public Version Number

1

DI Record Publish Date

October 22, 2018

Package DI Number

EJUVBP048

Quantity per Package

10

Contains DI Package

EJUVBP047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Heat sealed pack