Catalog Number

-

Brand Name

Magicore

Version/Model Number

552MC8008B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K212517

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

63551a48-439b-466f-b4a7-c9e48c28d407

Public Version Date

April 20, 2022

Public Version Number

1

DI Record Publish Date

April 12, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-