Identity
- Trade Name
- SonoTT Vascular Probe FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system, line-powered FDA UDI
- Device Name
- High quality workmanship Ultrasonic Flow Probes for the measurement of blood flow in vessels and grafts. The probes are showing excellent accuracy and stability. Calibration data are stored in the probe. The probes can be manually and automatically cleaned and disinfected and sterilized with steam, ethylene oxide (EtO), low temperature steam and form - aldehyde sterilisation (LTSF) and low temperature plasma (LTP). We support up to 50 sterilisation cycles FDA UDI
- Model / Reference
- 11343 FDA UDI
- Description
- High quality workmanship Ultrasonic Flow Probes for the measurement of blood flow in vessels and grafts. The probes are showing excellent accuracy and stability. Calibration data are stored in the probe. The probes can be manually and automatically cleaned and disinfected and sterilized with steam, ethylene oxide (EtO), low temperature steam and form - aldehyde sterilisation (LTSF) and low temperature plasma (LTP). We support up to 50 sterilisation cycles FDA UDI
Identifiers
- Catalog Number
- 11343 FDA UDI
- Primary DI / UDI-DI
- 04062114000112 FDA UDI
- 510(k) Number
- K111730 FDA UDI
- FDA Product Code
- DPW FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2100 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SonoTT Vascular Probe by em-tec GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K111730 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 II | Pending data |
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Manufacturer
- Manufacturer
- em-tec GmbH
Sources (1)
- FDA UDI d2fa4424-fa66-41f1-ad6a-e9bdcc967f8b 37 fields · synced May 30, 2026