Identity
- Trade Name
- SonicOne O.R FDA UDI
- Generic Name
- Wound therapy ultrasound system handpiece FDA UDI
- Device Name
- SonicOne O.R Handpiece Kit COMPRISES OF SOM-HP, BCM-H2 (MEDICAL DEVICE ) BCM-CBS, BCM-CBL, BCM-CW, E-PWRCH, BCM-UM-USB (NON-MEDICAL DEVICES) FDA UDI
- Model / Reference
- SOM-HP KIT FDA UDI
- Description
- SonicOne O.R Handpiece Kit COMPRISES OF SOM-HP, BCM-H2 (MEDICAL DEVICE ) BCM-CBS, BCM-CBL, BCM-CW, E-PWRCH, BCM-UM-USB (NON-MEDICAL DEVICES) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841626102040 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Wound therapy ultrasound system handpiece FDA UDI
Classification
- Device Class
- U 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Wound therapy ultrasound system handpiece
SonicOne O.R by Misonix, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound therapy ultrasound system handpiece.
- UltraMIST Treatment Wand — ALLIQUA BIOMEDICAL, 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 U | Pending data |
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Manufacturer
- Manufacturer
- Misonix, LLC
Sources (1)
- FDA UDI 762c8d87-3d0f-4bb3-9142-5cff25ea0efd 33 fields · synced Jun 9, 2026