Identity
- Trade Name
- neXus FDA UDI
- Generic Name
- Wound therapy ultrasound system handpiece tip FDA UDI
- Device Name
- neXus SonicOne® O.R. Hatched Probe & Tubeset FDA UDI
- Model / Reference
- 120-31-10X1 FDA UDI
- Description
- neXus SonicOne® O.R. Hatched Probe & Tubeset FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841626103092 FDA UDI
- 510(k) Number
- K190160 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Wound therapy ultrasound system handpiece tip FDA UDI
Classification
- Device Class
- U 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound therapy ultrasound system handpiece tip
neXus 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 tip.
- UltraMIST Applicator — ALLIQUA BIOMEDICAL, INC. · Class II
- MIST 360 Applicator — ALLIQUA BIOMEDICAL, INC. · Class II
- MIST Therapy Applicator — ALLIQUA BIOMEDICAL, INC. · Class II
- neXus — Misonix, LLC · U
- neXus — Misonix, LLC · U
- neXus — Misonix, LLC · U
- neXus — Misonix, LLC · U
Cleared under the same submission
K190160 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Misonix, LLC
Sources (1)
- FDA UDI f53231b7-6fda-4d46-9e0c-6ff4b7d3c132 34 fields · synced Jun 9, 2026