Catalog Number

665950

Brand Name

digit Power™ Dispenser

Version/Model Number

678062

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2021

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

EHZ

Product Code Name

Evacuator, oral cavity

Public Device Record Key

a63cbf41-3a8e-489e-9c90-aa9eb06ac47d

Public Version Date

October 03, 2022

Public Version Number

3

DI Record Publish Date

April 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-