Catalog Number

DP02

Brand Name

Dentapen Finger Grip

Version/Model Number

Finger Grip 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

f91a4bb7-3130-44c4-b95f-73bcd44a94e7

Public Version Date

November 22, 2018

Public Version Number

1

DI Record Publish Date

October 22, 2018

Package DI Number

EJUVDP028

Quantity per Package

5

Contains DI Package

EJUVDP027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box