Catalog Number

101-1401

Brand Name

Soft Prep

Version/Model Number

101-1401

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

EKQ

Product Code Name

Preparer, Root Canal Endodontic

Public Device Record Key

d31c035c-cc3d-4ca7-b272-a556e0a54238

Public Version Date

August 24, 2018

Public Version Number

3

DI Record Publish Date

February 20, 2017

Package DI Number

00200101160676

Quantity per Package

150

Contains DI Package

08809262954302

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-