Identity
- Trade Name
- MAR0Fuse FDA UDI
- Generic Name
- Bone matrix implant, human-derived FDA UDI
- Device Name
- MAR0Fuse Demineralized Bone Matrix Gel FDA UDI
- Model / Reference
- MAR0Fuse5cc FDA UDI
- Description
- MAR0Fuse Demineralized Bone Matrix Gel FDA UDI
Identifiers
- Primary DI / UDI-DI
- M896MAR0FUSE5CC1 FDA UDI
- FDA Product Code
- MQV FDA UDIMBP FDA UDI
- GMDN Term
- Bone matrix implant, human-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
MAR0Fuse by Arteriocyte Medical Systems, 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
- Arteriocyte Medical Systems, Inc.
Sources (1)
- FDA UDI b284deee-aa60-4053-942f-a7002eb0b348 37 fields · synced Jun 1, 2026