Identity
- Trade Name
- OSUNG MND FDA UDI
- Generic Name
- Bone graft syringe, reusable FDA UDI
- Device Name
- A calibrated barrel (cylinder) with plunger intended to be used to aspirate bone graft materials (e.g., autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic/composite bone matrix graft materials) and deliver them to a surgical site during an orthopaedic, oral, or maxillofacial surgical procedure. This is a reusable device. FDA UDI
- Model / Reference
- BSY70 FDA UDI
- Description
- A calibrated barrel (cylinder) with plunger intended to be used to aspirate bone graft materials (e.g., autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic/composite bone matrix graft materials) and deliver them to a surgical site during an orthopaedic, oral, or maxillofacial surgical procedure. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800075603517 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Bone graft syringe, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone graft syringe, reusable
Osung Mnd by Osung Mnd Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone graft syringe, reusable.
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- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
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- GRAFT MATERIAL CARRIER D/E — W.H. Holden, Inc. · Class I
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
- SPOON-COMPACTOR BONE INST. — W.H. Holden, Inc. · Class I
- SPOON COMPACTOR BONE INST 4mm — W.H. Holden, Inc. · Class I
- GRAFT MATERIAL SPATULA / CARRIER — W.H. Holden, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Osung Mnd Co., Ltd.
Sources (1)
- FDA UDI 40a9a5a6-938c-4e9a-87f3-3b941ad67ddb 33 fields · synced May 30, 2026