Identity
- Trade Name
- HARVEST® FDA UDI
- Generic Name
- Bone graft delivery kit FDA UDI
- Device Name
- BBAN-10 Needles(BMAC/BMAC2)11Ga X 110mm FDA UDI
- Model / Reference
- 51447 FDA UDI
- Description
- BBAN-10 Needles(BMAC/BMAC2)11Ga X 110mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05020583514478 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Bone graft delivery kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
The HARVEST device is a single-use bone graft delivery kit used in orthopaedic surgical procedures. It allows for the aspiration and/or premixing of various bone graft materials, including marrow, blood, plasma, IVF, and synthetic fillers.
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 |
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Manufacturer
- Manufacturer
- Terumo BCT, Inc..
Sources (1)
- FDA UDI 76086518-afec-4efb-940c-8d101701685d 36 fields · synced Jun 27, 2026