Duns Number:185444825
Device Description: E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, L-Wire 33 cm., Single-Use, E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, L-Wire 33 cm., Single-Use, for use with hand control pencil
Catalog Number
-
Brand Name
Megadyne
Version/Model Number
0100J
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
44ec763f-eb14-4334-8980-524e6e8a00e4
Public Version Date
December 31, 2021
Public Version Number
5
DI Record Publish Date
September 04, 2018
Package DI Number
30614559105850
Quantity per Package
6
Contains DI Package
10614559105856
Package Discontinue Date
December 31, 2021
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |