FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Solum IV Graft Kit Plus 5cc
DI: 00810025870089
·
Model: 1205-2000
·
Celling Biosciences
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Solum IV Graft Kit Plus 5cc
- Primary DI
- 00810025870089
- Version / Model
- 1205-2000
- Catalog Number
- XXXX
- Company Name
- Celling Biosciences
- Labeler DUNS
- 021560394
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-23
- Public Version
- 2
- Public Version Date
- 2025-04-14
- Public Version Status
- Update
- Public Device Record Key
- 8b17c94e-bdf9-4fc4-aaa4-b7abd25157a6
- Distribution End Date
- 2025-04-11
Device Description
Solum IV 5cc w/ BMC Plus Processing Kit - UDI is not correct per current DI# configuration.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | 862.2050 | 1 |
| 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 |
| 47153 | Haematological concentrate system preparation kit, bone marrow concentration | A collection of sterile devices typically used at the point-of-care for the rapid preparation of autologous bone marrow aspirate concentrate (BMAC) from bone marrow aspirate. The kit components, with the bone marrow aspirate, are directly placed in a dedicated centrifuge that separates and concentrates the bone marrow. The cellular BMAC preparations are typically applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. The kit may include specimen drawing devices. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810025870089 | GS1 |