Duns Number:117402924
Device Description: Electrosurgical RF Multitined Expandable Electrode
Catalog Number
-
Brand Name
Nimbus
Version/Model Number
NIM-100-10BB-CS
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
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
K121773,K121773
Product Code
GXI
Product Code Name
Probe, Radiofrequency Lesion
Public Device Record Key
9d8648f0-ea13-40fc-af9a-8a6eafe60fd3
Public Version Date
September 20, 2022
Public Version Number
1
DI Record Publish Date
September 12, 2022
Package DI Number
10850040767015
Quantity per Package
10
Contains DI Package
00850040767018
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |