Duns Number:313163545
Device Description: Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, mixture with diameters 4 mm an Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, mixture with diameters 4 mm and 6 mm, 30 ml
Catalog Number
6.2/7.2CB0406
Brand Name
Synthacer/Syntricer
Version/Model Number
T672CB0406-30-1
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
K041177
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
57657252-5360-4e6c-85bc-340d034269d3
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
October 24, 2015
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. | 753 |