Catalog Number

-

Brand Name

Magicore R 454M4011

Version/Model Number

Magicore R

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152520,K201981

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

8cd810b1-3ac1-4dd5-8d57-21eb9e86e634

Public Version Date

September 11, 2020

Public Version Number

2

DI Record Publish Date

October 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-