Catalog Number

03-622-632

Brand Name

OVATION®

Version/Model Number

03-622-632

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 15, 2021

Issuing Agency

In HIBCC

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

DZC

Product Code Name

WIRE, ORTHODONTIC

Public Device Record Key

a49b64b6-2117-4296-9960-5a90180245a5

Public Version Date

January 15, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-