Catalog Number

-

Brand Name

HurriSeal Dentin Desensitizer Snap-N-Go Swab

Version/Model Number

Snap-N-Go Swab

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

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

K973002,K973002,K973002,K973002,K973002,K973002,K973002,K973002,K973002,K973002

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Public Device Record Key

e139c151-5199-43f9-914e-13b28cb3f8ad

Public Version Date

April 30, 2021

Public Version Number

7

DI Record Publish Date

October 01, 2016

Package DI Number

02723797697113

Quantity per Package

3000

Contains DI Package

00723797697115

Package Discontinue Date

April 30, 2021

Package Status

Not in Commercial Distribution

Package Type

3000 count bulk case