Duns Number:604056226
Device Description: Electro Lube is a single patient use device that is intended to be used on electrosurgical Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
Catalog Number
-
Brand Name
Key Surgical Electro Lube
Version/Model Number
EL-101
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
K033880,K033880
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
4a7cc300-dee2-45ab-b483-4daaddb0fa8d
Public Version Date
September 08, 2021
Public Version Number
3
DI Record Publish Date
September 11, 2019
Package DI Number
10849771037870
Quantity per Package
20
Contains DI Package
00849771037873
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |