Duns Number:627879687
Device Description: The Reusable monopolar active cord is intended to deliver monopolar electrical current fro The Reusable monopolar active cord is intended to deliver monopolar electrical current from the electrosurgical unit to electrosurgical devices or accessories requiring monopolar electrical current during endoscopic procedures.
Catalog Number
00711005
Brand Name
NA
Version/Model Number
00711005
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
dfa11699-8e54-48d4-930a-502250b7b8b7
Public Version Date
November 10, 2020
Public Version Number
3
DI Record Publish Date
February 07, 2020
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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |