Duns Number:801089152
Device Description: IsoTis Mozaik™ Moldable Morsels Mega, 2 X 7.5cc - A resorbable bone void filler made from IsoTis Mozaik™ Moldable Morsels Mega, 2 X 7.5cc - A resorbable bone void filler made from microfibrillar collagen combined with tricalcium phosphate (TCP) granules and cubes.
Catalog Number
MSL150
Brand Name
IsoTis Mozaik Moldable Morsels
Version/Model Number
MSL150
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
K091302
Product Code
MQV
Product Code Name
FILLER, BONE VOID, CALCIUM COMPOUND
Public Device Record Key
cf02a623-b93b-45c2-a291-75d7c6810c50
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 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. | 101 |