Catalog Number

-

Brand Name

Crest Sensi-Stop Strips

Version/Model Number

2ct

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

00154630-8c8f-4ffc-9cc6-cde672eba253

Public Version Date

August 13, 2019

Public Version Number

5

DI Record Publish Date

July 31, 2016

Package DI Number

10037000860157

Quantity per Package

24

Contains DI Package

00037000560159

Package Discontinue Date

November 04, 2017

Package Status

Not in Commercial Distribution

Package Type

box