Catalog Number

FSU218

Brand Name

Resolve Ceramic

Version/Model Number

FSU218

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 2019

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"

Yes

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

DYW

Product Code Name

BRACKET, PLASTIC, ORTHODONTIC

Public Device Record Key

529bf72d-285c-4d4e-80f3-b6509e41f21e

Public Version Date

May 06, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-