Duns Number:313163545
Device Description: Synthacer® 1000 granules, HA, particle size 2.6 - 4.8 mm, 2 ml
Catalog Number
6.3G03
Brand Name
Synthacer
Version/Model Number
T63G03-2-1
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
d66a77f3-ae34-40de-b54c-37abb3215f01
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 |