Duns Number:079375431
Device Description: HALYARD* RF Probe Kit, Curved-20-100-Yellow
Catalog Number
PMK-20-100C
Brand Name
Halyard
Version/Model Number
98664
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"
-
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
K002389
Product Code
GXI
Product Code Name
PROBE, RADIOFREQUENCY LESION
Public Device Record Key
38582b07-232b-46e8-afb6-e99fc2be9f71
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
February 08, 2017
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 |