Duns Number:069261402
Device Description: Foot temperature probe for Smartdop Dopplers.
Catalog Number
TP-02
Brand Name
Temp probe
Version/Model Number
TP-02
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 07, 2017
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131623
Product Code
JOP
Product Code Name
Transducer, Ultrasonic
Public Device Record Key
00dd5c21-7d72-4eee-8cf1-3091942a0ae9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 25, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |