Catalog Number

861-201

Brand Name

Ortho Wax Bites

Version/Model Number

861-201

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EGD

Product Code Name

WAX, DENTAL, INTRAORAL

Public Device Record Key

8f01d110-5ca4-4193-b3e5-d557589973bf

Public Version Date

October 05, 2022

Public Version Number

3

DI Record Publish Date

April 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-