Catalog Number

55-1111-00S1

Brand Name

EXPERIENCE®

Version/Model Number

55-111100S1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

EJF

Product Code Name

BRACKET, METAL, ORTHODONTIC

Public Device Record Key

963d9e83-eb5f-415a-a7fc-89ca883c0e84

Public Version Date

December 31, 2020

Public Version Number

1

DI Record Publish Date

December 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-