Identity
- Trade Name
- SeriVium FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- The SeriVium Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. FDA UDI
- Model / Reference
- 510355 FDA UDI
- Description
- The SeriVium Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. FDA UDI
Identifiers
- Catalog Number
- 510355 FDA UDI
- Primary DI / UDI-DI
- 00850014593636 FDA UDI
- FDA Product Code
- ORG FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Commercial Distribution
- 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
Dimensions & Sizes
- Size
- Total Volume — 60 Milliliter FDA UDI
Category: Haematological concentrate system preparation kit, platelet concentration
SeriVium by Royal Biologics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haematological concentrate system preparation kit, platelet concentration.
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Cleared under the same submission
BK120008 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Royal Biologics, Inc.
Sources (1)
- FDA UDI 086ddf43-3552-4116-9731-2c65d08407ca 38 fields · synced May 31, 2026