Duns Number:079375431
Device Description: HALYARD* Radiofrequency Probes-Steam Sterilizable-Reusable-18-145-Straight-Black-Black (Pi HALYARD* Radiofrequency Probes-Steam Sterilizable-Reusable-18-145-Straight-Black-Black (Pink Stylet)
Catalog Number
PMP-18-145
Brand Name
Halyard
Version/Model Number
98678
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
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
K071745
Product Code
GXI
Product Code Name
PROBE, RADIOFREQUENCY LESION
Public Device Record Key
487e8962-4643-4c51-a707-0dae55af0107
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 26, 2019
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 | 269 |
2 | A medical device with a moderate to high risk that requires special controls. | 5221 |