Identity
- Trade Name
- Stimulan® Pellets FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 600-48-010 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 600-48-010 FDA UDI
- Primary DI / UDI-DI
- 15060155710072 FDA UDI
- 510(k) Number
- K001724 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 4.8 Millimeter FDA UDI
Category: Synthetic bone graft
Stimulan® Pellets by Biocomposites Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K001724 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biocomposites Ltd
Sources (1)
- FDA UDI 7cb5dac9-29df-4f83-9b97-65935c81501c 38 fields · synced May 30, 2026