Duns Number:618493741
Device Description: Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guided intraute Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, two model DE-001 single-use electrosurgical return electrodes, and one model ACCY-007 sterile single-use electrosurgical handpiece cable.
Catalog Number
PROKIT-001
Brand Name
Sonata® Procedure Kit
Version/Model Number
PROKIT-001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 02, 2022
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
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
K193516
Product Code
KNF
Product Code Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Public Device Record Key
a6e12304-3933-417a-9045-626cf29d9819
Public Version Date
July 19, 2022
Public Version Number
2
DI Record Publish Date
October 07, 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. | 15 |