Catalog Number

-

Brand Name

ORTHOSOURCE

Version/Model Number

557-412

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K861245

Product Code

EBC

Product Code Name

Sealant, Pit And Fissure, And Conditioner

Public Device Record Key

9b649e9a-de46-4a9d-8e50-291a4df42371

Public Version Date

December 25, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-