Identity
- Trade Name
- neXus FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- neXus Standard Sterilization Tray FDA UDI
- Model / Reference
- 100-70-0000 FDA UDI
- Description
- neXus Standard Sterilization Tray FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841626102606 FDA UDI
- 510(k) Number
- K190160 FDA UDI
- FDA Product Code
- LFL FDA UDIGEI FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Device sterilization/disinfection container, reusable
neXus by Misonix, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 62d03535-6876-458e-bba8-0d7a11be2a9a 34 fields · synced Jun 9, 2026