Duns Number:904569092
Device Description: IMPLANTE CM Ø3,5 X 15,0MM
Catalog Number
ILCM 3515
Brand Name
Epikut
Version/Model Number
ILCM 3515
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
K211921
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
b0d29cd7-aac0-456c-8215-b43835109035
Public Version Date
January 25, 2022
Public Version Number
1
DI Record Publish Date
January 17, 2022
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1337 |