Duns Number:003506272
Device Description: OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bo OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® 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
44-100-00-BSI
Brand Name
OsteoCrete® Bone Void Filler
Version/Model Number
10cc
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 18, 2020
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
b04e93c7-7802-470a-a709-a9929a066c65
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
August 04, 2017
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 |