Duns Number:424382307
Device Description: Stimulan® DS Calcium Sulfate Bone Void Filler is provided sterile for single patient use. Stimulan® DS Calcium Sulfate Bone Void Filler is provided sterile for single patient use. The kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together, the resultant paste is to be injected or digitally packed into open bone/gap to cure insitu. The biodegradable, radiopaque mixture is resorbed in approximately 30-60 days when used in accordance with the device labelling. Stimulan® is manufactured from synthetic implant grade calcium sulfate dihydrate (CaS04, 2H20) that resporbs and is replaced with bone during the healing process. Also as the bone void filler is biodegradable and biocompatible; it may be used at an infected site.
Catalog Number
640-005
Brand Name
Stimulan® DS
Version/Model Number
640-005
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
-
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
de0d122f-27b0-409d-b658-3c107ce1d1f9
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 |