Identity
- Trade Name
- Mixing and Delivery System FDA UDI
- Generic Name
- Bone graft delivery kit FDA UDI
- Device Name
- The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. FDA UDI
- Model / Reference
- Mechanical Advantage Pak FDA UDI
- Description
- The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. FDA UDI
Identifiers
- Catalog Number
- RM 44-051 FDA UDI
- Primary DI / UDI-DI
- B447RM4405110 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Mixing and Delivery System by Bone Solutions, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Bone Solutions, Inc.
Sources (1)
- FDA UDI 8448f0cc-ac99-4a1a-95b6-f634c2368048 36 fields · synced Jun 8, 2026