Duns Number:424382307
Device Description: Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site.
Catalog Number
600-30-s1
Brand Name
Stimulan® Dispenser
Version/Model Number
600-30-s1
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
K001724,K001724
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
73e71e62-27bb-4d7f-b56e-cfbfb4e5b648
Public Version Date
January 15, 2020
Public Version Number
1
DI Record Publish Date
January 07, 2020
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. | 89 |