Identity
- Trade Name
- Trophon EPR FDA UDI
- Generic Name
- Atomized-chemical device disinfector FDA UDI
- Device Name
- Trophon US Refurbished FDA UDI
- Model / Reference
- N00010-US-RFB FDA UDI
- Description
- Trophon US Refurbished FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09350855000122 FDA UDI
- 510(k) Number
- K103059 FDA UDI
- FDA Product Code
- OUJ FDA UDI
- GMDN Term
- Atomized-chemical device disinfector 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Atomized-chemical device disinfector
Trophon EPR by Nanosonics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Atomized-chemical device disinfector.
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- trophon2 — NANOSONICS, INC. · Class II
- Trophon EPR — NANOSONICS, INC. · Class II
- Trophon EPR — NANOSONICS, INC. · Class II
- trophon3 — NANOSONICS, INC. · Class II
Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Nanosonics, Inc.
Sources (1)
- FDA UDI 96ab12f0-86f4-4665-b211-dc9fb963204c 34 fields · synced Jun 6, 2026