Identity
- Trade Name
- Osseo II Bone Trap FDA UDI
- Generic Name
- Orthopaedic surgery tissue debris collector, single-use FDA UDI
- Device Name
- Osseous Bone Trap FDA UDI
- Model / Reference
- OSSF FDA UDI
- Description
- Osseous Bone Trap FDA UDI
Identifiers
- Catalog Number
- OSSF FDA UDI
- Primary DI / UDI-DI
- D867OSSF0 FDA UDI
- FDA Product Code
- MXP FDA UDI
- GMDN Term
- Orthopaedic surgery tissue debris collector, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4800 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic surgery tissue debris collector, single-use
Osseo II Bone Trap by Xemax Surgical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic surgery tissue debris collector, single-use.
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- Osteomedix, Inc. — OSTEOMEDIX, INC. · Class II
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- spineX BONE DUST COLLECTOR — Oto-Med, Inc. · Class II
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
- Xemax Surgical Products, Inc.
Sources (1)
- FDA UDI fc2ca682-20a2-4f74-986e-3d89db7e8ec3 34 fields · synced Jun 1, 2026