Duns Number:631169224
Catalog Number
-
Brand Name
Magicore R 452M4011
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
add12d72-f268-4ced-9223-7dde39ea59e4
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
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 755 |
2 | A medical device with a moderate to high risk that requires special controls. | 1844 |