← Back to catalogue
OsteoPrecision Graft Delivery Device
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GD-1015-150Ref GD-1015-050
Identity
- Trade Name
- OsteoPrecision Graft Delivery Device EUDAMEDOSTEOPRECISION FDA UDI
- Generic Name
- Bone graft delivery kit FDA UDI
- Device Name
- Graft Delivery Device EUDAMEDOsteoPrecision Non-Vented/Closed System 5cm Cannula FDA UDI
- Model / Reference
- GD-1015-150 EUDAMEDGD-1015-050 EUDAMEDFDA UDI
- Description
- OsteoPrecision Non-Vented/Closed System 5cm Cannula FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20815634020393 EUDAMED10815634020372 EUDAMED00815634020375 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20815634020393 EUDAMEDB-10815634020372 EUDAMEDB-00815634020375 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
OsteoPrecision Graft Delivery Device 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-20815634020393 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micromedics, Inc.
- EUDAMED SRN
- US-MF-000018365
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED 5433d58e-1496-4050-99d3-44e5cd5df6d5 61 fields · synced Aug 2, 2026
- EUDAMED 0bea56be-c5f4-49de-a299-deaab0bbff09 61 fields · synced May 17, 2026
- EUDAMED ab9a17b0-1fb7-47a1-ad5f-3985ea02c2a3 61 fields · synced May 17, 2026
- FDA UDI 93270311-8f9d-4410-a07d-0b3b9aef25bb 34 fields · synced May 30, 2026