Catalog Number

852-758

Brand Name

Ortho Band

Version/Model Number

852-758

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 27, 2019

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

DZB

Product Code Name

Headgear, Extraoral, Orthodontic

Public Device Record Key

95312b83-aa4d-4995-a550-d876397f0d73

Public Version Date

June 18, 2020

Public Version Number

5

DI Record Publish Date

December 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-