Duns Number:424382307
Device Description: STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium su STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be injected or digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Kit is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site.
Catalog Number
600-005
Brand Name
Stimulan® Kit
Version/Model Number
600-005
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"
Yes
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
K141830,K141830
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
fd7a92e6-9f2e-4e01-9ee8-ac3c8b3b5167
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 |