Identity
- Trade Name
- OSTEOPRECISION FDA UDI
- Generic Name
- Bone graft delivery kit FDA UDI
- Device Name
- OsteoPrecision Vented System, Hydration Adapter, 5cm Cannula FDA UDI
- Model / Reference
- GD-1115-050 FDA UDI
- Description
- OsteoPrecision Vented System, Hydration Adapter, 5cm Cannula FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815634020405 FDA UDI
- 510(k) Number
- K151543 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
- 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
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
Category: Bone graft delivery kit
Osteoprecision by Micromedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151543 also covers:
- Biocomposites — Micromedics, Inc.
- HC Biologics — Micromedics, Inc.
- Nordson Medical — Micromedics, Inc.
- Nordson Medical — Micromedics, Inc.
- OSTEOPRECISION — Micromedics, Inc.
- OSTEOPRECISION — Micromedics, Inc.
- OSTEOPRECISION — Micromedics, Inc.
- OSTEOPRECISION — Micromedics, Inc.
- OsteoPrecision — Micromedics, Inc.
- OsteoPrecision — Micromedics, Inc.
- OsteoPrecision — Micromedics, Inc.
- OsteoPrecision — Micromedics, Inc.
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
- Micromedics, Inc.
Sources (1)
- FDA UDI 30dd8bf8-a9ce-4681-973a-1ac40c6666ca 34 fields · synced Jun 8, 2026