FDA UDI
In Commercial Distribution
🇺🇸 United States
trophon3
DI: 09350855000740
·
Model: N05035-US
·
NANOSONICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- trophon3
- Primary DI
- 09350855000740
- Version / Model
- N05035-US
- Company Name
- NANOSONICS LIMITED
- Labeler DUNS
- 741021943
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-14
- Public Version
- 1
- Public Version Date
- 2025-08-22
- Public Version Status
- New
- Public Device Record Key
- 2eddf829-3dc0-4cf0-a4bb-a425b7ffc65d
Device Description
Contents: 1 x N05035-1 trophon3 10 x N05006 trophon AcuTrace Operator Card 10 X N05007 trophon AcuTrace Medical Instrument Tag
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OUJ | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66654 | Atomized-chemical device disinfector | An electrically-powered unit designed for the disinfection of devices at the point-of-use using ultrasonically generated ultra-fine particle aerosolized disinfectant. It consists of a cabinet (e.g., with internal shelves) intended to accept pre-cleaned medical devices/equipment (including electrical devices), an ultrasonic disinfectant atomizer and a control panel. It is intended to be used as an alternative to wipe down disinfection, and is not intended for use in a reprocessing suite. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09350855000740 | GS1 |
Customer Contacts
- Phone
- 1-844-876-7466
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250434 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- -20 °C to +60 °C / -4 °F to +140 °F