Duns Number:003506272
Device Description: Mg OSTEOINJECT® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOIN Mg OSTEOINJECT® is an injectable, moldable, and biocompatible Bone Void Filler. Mg OSTEOINJECT® Bone Void Filler Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.
Catalog Number
44-050-00-INJ
Brand Name
Mg OSTEOINJECT® Bone Void Filler
Version/Model Number
5cc
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
908d14ec-c633-47f5-b480-1dadea71ab08
Public Version Date
January 19, 2022
Public Version Number
1
DI Record Publish Date
January 11, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |