Duns Number:046355210
Device Description: 30.2cm Disposable Monopolar Electrode, Blunt Tip
Catalog Number
-
Brand Name
Kirwan
Version/Model Number
30-6012
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 04, 2018
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,K895331
Product Code
JOS
Product Code Name
Electrode, Electrosurgical
Public Device Record Key
00e02b33-4785-4406-96d0-f6cad2f816f5
Public Version Date
January 31, 2022
Public Version Number
6
DI Record Publish Date
May 04, 2016
Package DI Number
20841019108066
Quantity per Package
4
Contains DI Package
00841019108062
Package Discontinue Date
April 04, 2018
Package Status
Not 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 |