Duns Number:939872651
Device Description: Myocardial Needle Temperature Probe
Catalog Number
-
Brand Name
Myocardial Needle Temperature Probe
Version/Model Number
2426
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K813459,K813459
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
54cf9daa-7ab8-4cef-904f-4df84cba33d6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 01, 2017
Package DI Number
B04024262T
Quantity per Package
1
Contains DI Package
B04024261
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 53 |