FDA UDI
In Commercial Distribution
🇺🇸 United States
Stimulan® Dispenser
DI: 15060155710096
·
Model: 600-30-s1
·
BIOCOMPOSITES LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Stimulan® Dispenser
- Primary DI
- 15060155710096
- Version / Model
- 600-30-s1
- Catalog Number
- 600-30-s1
- Company Name
- BIOCOMPOSITES LTD
- Labeler DUNS
- 424382307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-07
- Public Version
- 1
- Public Version Date
- 2020-01-15
- Public Version Status
- New
- Public Device Record Key
- 73e71e62-27bb-4d7f-b56e-cfbfb4e5b648
Device 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.
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
- No
- 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 | 15060155710096 | GS1 | ||||
| Previous | 50601557100998 | GS1 |
Customer Contacts
- Phone
- +441782338580
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K001724 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 3 | Millimeter | |
| Device Size Text, specify | 1.5cc |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 45 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 113 Degrees Fahrenheit