Identity
- Trade Name
- Stimulan Kit 5cc (CHINA ONLY) FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- (CHINA ONLY) Stimulan® Calcium Sulphate Kit is provided sterile for single patient use. The Kit contains calcium sulphate powder. When the powder is mixed with sterile water in a sterile mixing bowl, the resultant paste is to be injected, digitally packed into open bone void/gap to cure in situ or placed into a mould, the mixture sets to form Stimulan® pellets. The biodegradable, radiopaque pellets are resorbed in approximately 30 - 60 days when used in accordance with the device labelling. FDA UDI
- Model / Reference
- 600-005 FDA UDI
- Description
- (CHINA ONLY) Stimulan® Calcium Sulphate Kit is provided sterile for single patient use. The Kit contains calcium sulphate powder. When the powder is mixed with sterile water in a sterile mixing bowl, the resultant paste is to be injected, digitally packed into open bone void/gap to cure in situ or placed into a mould, the mixture sets to form Stimulan® pellets. The biodegradable, radiopaque pellets are resorbed in approximately 30 - 60 days when used in accordance with the device labelling. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15060155711567 FDA UDI
- 510(k) Number
- K141830 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
Category: Synthetic bone graft
Stimulan Kit 5cc (CHINA ONLY) by Biocomposites Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Synthetic bone graft.
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- OsseoSculpt Moldable ABG, 3cc — Biogennix, LLC · Class II
- Montage Settable Bone Putty — ABYRX, INC. · Class II
- IngeniOS HA — curasan AG · Class II
- Osbone Dental — curasan AG · Class II
- Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II
Cleared under the same submission
K141830 also covers:
- Stimulan Kit 10cc (CHINA ONLY) — BIOCOMPOSITES LTD
- Stimulan Rapid Cure 10cc (CHINA ONLY) — BIOCOMPOSITES LTD
- Stimulan Rapid Cure 20cc (CHINA ONLY) — BIOCOMPOSITES LTD
- Stimulan Rapid Cure 5cc (CHINA ONLY) — BIOCOMPOSITES LTD
- Stimulan® Kit — BIOCOMPOSITES LTD
- Stimulan® Kit — BIOCOMPOSITES LTD
- Stimulan® Rapid Cure — BIOCOMPOSITES LTD
- Stimulan® Rapid Cure — BIOCOMPOSITES LTD
- Stimulan® Rapid Cure — BIOCOMPOSITES LTD
- Stimulan® Rapid Cure — BIOCOMPOSITES LTD
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 aec004c6-effd-4841-9ce7-ba4f29f290a2 37 fields · synced Jun 8, 2026