Duns Number:239403863
Device Description: The Monopolar Cables are for use with a variety of Monopolar instruments with a universal The Monopolar Cables are for use with a variety of Monopolar instruments with a universal offset diathermy post connection & compatible for use with a wide variety of makes of electrosurgical diathermy generators.
Catalog Number
PS3551C8
Brand Name
Monopolar cable with 4mm connector
Version/Model Number
PS3551C4
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
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
6fb3fbc1-60be-4826-8566-040d76a0d7f1
Public Version Date
May 08, 2018
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
35051223005927
Quantity per Package
5
Contains DI Package
05051223005926
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shelf box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |