Duns Number:320025190
Device Description: SonoTT Vascular Probe: The SonoTT Vascular Probes for measuringflow in blood vessels are a SonoTT Vascular Probe: The SonoTT Vascular Probes for measuringflow in blood vessels are available in different sizes forvessel diameters of 1.5 to 10 mm (more sizes on request).The probes can be sterilised up to 50 times using all establishedsterilisation methods (steam, EO, LTP, Formaldehyde).Automatic washing machines can be used to clean the probes.
Catalog Number
11940
Brand Name
SonoTT Vascular Probe
Version/Model Number
11940
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 20, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111730
Product Code
DPW
Product Code Name
Flowmeter, Blood, Cardiovascular
Public Device Record Key
8c5bda13-e4a6-4401-b1ea-cde1bbc1bbfb
Public Version Date
October 22, 2018
Public Version Number
1
DI Record Publish Date
September 20, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |