Identity
- Trade Name
- COX BONE DUST COLLECTOR FDA UDI
- Generic Name
- Otological bone particle collector FDA UDI
- Device Name
- COX BONE DUST COLLECTOR FDA UDI
- Model / Reference
- S-3500 FDA UDI
- Description
- COX BONE DUST COLLECTOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850000126060 FDA UDI
- FDA Product Code
- MXP FDA UDI
- GMDN Term
- Otological bone particle collector 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Otological bone particle collector
Cox Bone Dust Collector by Oto-Med, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Otological bone particle collector.
- EXMOOR — Exmoor Plastics , Ltd. · Class I
- EXMOOR — Exmoor Plastics , Ltd. · Class I
- SHEEHY BONE DUST COLLECTOR — Oto-Med, 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
- Oto-Med, Inc.
Sources (1)
- FDA UDI 7486fb60-05f8-456e-ad56-dcc1ec13eb1a 34 fields · synced May 30, 2026