Catalog Number

-

Brand Name

ORTHOSOURCE

Version/Model Number

557-424

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,K861245

Product Code

EBC

Product Code Name

Sealant, Pit And Fissure, And Conditioner

Public Device Record Key

d430f534-0a9c-436f-80b7-2e36f052c220

Public Version Date

November 20, 2019

Public Version Number

1

DI Record Publish Date

November 12, 2019

Package DI Number

D911557424K1

Quantity per Package

4

Contains DI Package

D9115574240

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

4 syr kit