Identity
- Trade Name
- OsteoXpress EUDAMEDGRAFT DELIVERY DEVICE FDA UDI
- Generic Name
- Bone graft delivery kit FDA UDI
- Device Name
- Graft Delivery Device EUDAMEDGraft Delivery Device - Molded Tray in Pouch FDA UDI
- Model / Reference
- GD-5515 EUDAMEDFDA UDI
- Description
- Graft Delivery Device - Molded Tray in Pouch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815634020634 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00815634020634 EUDAMED
- 510(k) Number
- K151543 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Bone graft delivery kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
OsteoXpress by Micromedics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00815634020634 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
- EUDAMED SRN
- US-MF-000018365
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED f1f8f16a-86d6-464f-89b2-9fdb9b9e2a38 61 fields · synced Jun 1, 2026
- FDA UDI a69026c0-81ca-4a01-b76b-22b59dad3cf9 34 fields · synced May 30, 2026