Ridge Preservation Kit - Cytoplast Technique
- Primary DI
- D765KITRPCT0
- Brand
- Ridge Preservation Kit - Cytoplast Technique
- Company
- Osteogenics Biomedical Inc
- Model
- KITRPCT
- Device description
- Ridge Preservation Kit - Cytoplast Technique; Includes: 1 sterile nonresorbable PTFE monofilament suture (model CS0518K) - USP 3-0, 18" length,16 mm 3/8 reverse cutting needle, 1 sterile nonresorbable PTFE membrane, textured (model TXT1224K) - 12 mm x 24 mm, 1 sterile GBM allograft (model C73050K) - 70% mineralized cortical bone matrix & 30% demineralized bone matrix
- Published
- 2017-11-20
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D765KITRPCT0 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Dental/maxillofacial surgical procedure kit, non-medicated, single-use | A collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 123853058
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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