Identity
- Trade Name
- Solum IV Graft Kit 5cc FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, bone marrow concentration FDA UDI
- Device Name
- Solum IV 5cc w/ BMC Processing Kit - UDI not correct per current DI# configuration. FDA UDI
- Model / Reference
- 1205-1000 FDA UDI
- Description
- Solum IV 5cc w/ BMC Processing Kit - UDI not correct per current DI# configuration. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810025870072 FDA UDI
- FDA Product Code
- JQC FDA UDIMQV FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, bone marrow concentration FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 FDA UDI888.3045 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Solum IV Graft Kit 5cc by Celling Biosciences — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Celling Biosciences
Sources (1)
- FDA UDI 82e3d24e-99e3-4cf7-9e77-4c781f46c1d9 34 fields · synced Jun 8, 2026