Identity
- Trade Name
- trophon Wireless Ultrasound Probe Holder FDA UDI
- Generic Name
- Device operating status label/tag, reusable FDA UDI
- Device Name
- Contains the following devices: 1 trophon Wireless Ultrasound Probe Holder (UDI: 09350855000511) 1 trophon AcuTrace Medical Instrument Tag (UDI: 09350855000283) FDA UDI
- Model / Reference
- N05030-US FDA UDI
- Description
- Contains the following devices: 1 trophon Wireless Ultrasound Probe Holder (UDI: 09350855000511) 1 trophon AcuTrace Medical Instrument Tag (UDI: 09350855000283) FDA UDI
Identifiers
- Catalog Number
- N05030-US FDA UDI
- Primary DI / UDI-DI
- 09350855000573 FDA UDI
- FDA Product Code
- OUJ FDA UDI
- GMDN Term
- Device operating status label/tag, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Device sterilization/disinfection container, reusableDevice operating status label/tag, reusable
trophon Wireless Ultrasound Probe Holder by Nanosonics, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nanosonics, Inc.
Sources (2)
- FDA UDI 58669dec-429f-446c-ab89-aab64ecce578 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026