Catalog Number

-

Brand Name

NAZORCAP Bite Guard

Version/Model Number

1801

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"

Yes

For Single-Use

Yes

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

BRW

Product Code Name

Protector, Dental

Public Device Record Key

d541a50e-ccad-4b26-b30e-51f599c85d1c

Public Version Date

September 24, 2018

Public Version Number

3

DI Record Publish Date

March 25, 2018

Package DI Number

10856824006080

Quantity per Package

50

Contains DI Package

00856824006083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box