Identity
- Trade Name
- SonoTT Vascular Probe FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system, line-powered FDA UDI
- Device Name
- SonoTT Vascular Probe: The SonoTT Vascular Probes for measuring flow in blood vessels are available in different sizes for vessel diameters of 1.5 to 10 mm (more sizes on request). The probes can be sterilised up to 50 times using all established sterilisation methods (steam, EO, LTP, Formaldehyde). Automatic washing machines can be used to clean the probes. FDA UDI
- Model / Reference
- 11345 FDA UDI
- Description
- SonoTT Vascular Probe: The SonoTT Vascular Probes for measuring flow in blood vessels are available in different sizes for vessel diameters of 1.5 to 10 mm (more sizes on request). The probes can be sterilised up to 50 times using all established sterilisation methods (steam, EO, LTP, Formaldehyde). Automatic washing machines can be used to clean the probes. FDA UDI
Identifiers
- Catalog Number
- 11345 FDA UDI
- Primary DI / UDI-DI
- 04062114000136 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 54cbe8b4-b5eb-47db-a475-3be9813ddd8c 37 fields · synced May 30, 2026