Duns Number:046355210
Device Description: 25cm Disposable Monopolar Electrode, Blunt Tip, 1.72mm Diameter
Catalog Number
-
Brand Name
Kirwan
Version/Model Number
30-6020
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
K895331,K895331,K895331
Product Code
JOS
Product Code Name
Electrode, Electrosurgical
Public Device Record Key
a98dde97-cce7-4a65-94e2-0b4ce3abc4cc
Public Version Date
February 07, 2022
Public Version Number
1
DI Record Publish Date
January 28, 2022
Package DI Number
10841019116903
Quantity per Package
4
Contains DI Package
00841019116906
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 60 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1505 |
| U | Unclassified | 2 |