Duns Number:185444825
Device Description: Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, L-Hook, Long, 38 c Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, L-Hook, Long, 38 cm., Reusable, For Use With Foot Control Pedal
Catalog Number
-
Brand Name
Megadyne
Version/Model Number
3020SA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K040699,K040699
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
c1592c2e-cf61-413b-b6ce-536f33ec63d4
Public Version Date
December 31, 2021
Public Version Number
5
DI Record Publish Date
July 31, 2020
Package DI Number
30614559102286
Quantity per Package
2
Contains DI Package
10614559102282
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 |