Duns Number:185444825
Device Description: E-Z Clean Electrosurgical 2.5 inches Electrode Blade for use with All-In-One Suction Irrig E-Z Clean Electrosurgical 2.5 inches Electrode Blade for use with All-In-One Suction Irrigation Pencil, 5mm x 6.35cm, Single-Use
Catalog Number
0080J
Brand Name
Megadyne
Version/Model Number
0080J
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
K922002,K922002,K922002
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
ec149f44-d1f8-4a5c-bd38-e2f7e39e4a6b
Public Version Date
June 11, 2021
Public Version Number
7
DI Record Publish Date
September 04, 2018
Package DI Number
50614559105373
Quantity per Package
40
Contains DI Package
10614559105375
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 |