FDA UDI
In Commercial Distribution
🇺🇸 United States
Stimulan Rapid Cure 20cc (CHINA ONLY)
DI: 15060155711550
·
Model: 620-020
·
BIOCOMPOSITES LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Stimulan Rapid Cure 20cc (CHINA ONLY)
- Primary DI
- 15060155711550
- Version / Model
- 620-020
- Company Name
- BIOCOMPOSITES LTD
- Labeler DUNS
- 424382307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-12
- Public Version
- 1
- Public Version Date
- 2022-11-21
- Public Version Status
- New
- Public Device Record Key
- b9f824ee-b6c2-4d96-8e37-31dfbb8fbdf3
Device Description
(CHINA ONLY) Stimulan® Calcium Sulphate (Stimulan® Rapid Cure) is provided sterile for single patient use The pack contains calcium sulphate powder and water. When the powder is mixed with sterile water in a sterile mixing bowl, the resultant paste is to be 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | 888.3045 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16966 | Synthetic bone graft | An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060155711550 | GS1 |
Customer Contacts
- Phone
- +4401782338580
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141830 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 20cc |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 45 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 113 Degrees Fahrenheit