Duns Number:618493741
Device Description: Convenience Kit containing one model RFA-001 sterile single-use ultrasound-guided intraute Convenience Kit containing one model RFA-001 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, and two model DE-001 single-use electrosurgical return electrodes
Catalog Number
CSKIT-001
Brand Name
Sonata® Case Kit
Version/Model Number
CSKIT-001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 30, 2020
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
K173703
Product Code
KNF
Product Code Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Public Device Record Key
c0baaf06-6121-4d62-83fa-e2573dfbe419
Public Version Date
May 19, 2021
Public Version Number
2
DI Record Publish Date
May 10, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |