Catalog Number

-

Brand Name

Crest Sensi-Stop Strips

Version/Model Number

10ct

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 04, 2017

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LBH

Product Code Name

VARNISH, CAVITY

Public Device Record Key

ab29f6bb-a744-4141-ac87-f0206cc6d09c

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

July 31, 2016

Package DI Number

10037000899195

Quantity per Package

12

Contains DI Package

00037000899198

Package Discontinue Date

November 04, 2017

Package Status

Not in Commercial Distribution

Package Type

box