Duns Number:531854560
Device Description: 1.5mm Multi-Point Thermal Sensor (MTS)
Catalog Number
FPRPR4020
Brand Name
MultiPoint 1.5 Thermal Sensor
Version/Model Number
FPRPR4020
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 14, 2020
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
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
-
Product Code
NEY
Product Code Name
System, Ablation, Microwave And Accessories
Public Device Record Key
324df954-792a-45db-af73-0bf79c16ece8
Public Version Date
September 03, 2021
Public Version Number
3
DI Record Publish Date
August 14, 2020
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. | 47 |