Duns Number:315304071
Device Description: COAG ELECTRODE MONO 10FR WL 400MM for cystoscopy, electrode shape: button, PACK=1 PC, reu COAG ELECTRODE MONO 10FR WL 400MM for cystoscopy, electrode shape: button, PACK=1 PC, reusable
Catalog Number
823.10
Brand Name
NA
Version/Model Number
82310
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JOS
Product Code Name
Electrode, electrosurgical
Public Device Record Key
0b58a7ce-c029-4612-ba27-5d1488a61a62
Public Version Date
April 09, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 587 |
2 | A medical device with a moderate to high risk that requires special controls. | 1835 |