Duns Number:185444825
Device Description: E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, J-Hook, Split Stem, 33 cm. E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, J-Hook, Split Stem, 33 cm., Single-Use, For Use With Foot Control Pedal
Catalog Number
0021S
Brand Name
Megadyne
Version/Model Number
0021S
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
K913281,K913281,K913281
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
2f42ce11-ca65-4898-b2ea-be3153d53c1e
Public Version Date
June 11, 2021
Public Version Number
10
DI Record Publish Date
December 06, 2016
Package DI Number
50614559100385
Quantity per Package
240
Contains DI Package
10614559100387
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |