Duns Number:185444825
Device Description: E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, Modified Exteneded Ins E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, Modified Exteneded Insulation 2.75 inch (7 cm), Bulk Non Sterile
Catalog Number
-
Brand Name
Megadyne
Version/Model Number
0012AMBN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 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
K081791,K862221,K081791,K862221
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
41c2e1b3-3df9-47b3-b368-411e5c1b937b
Public Version Date
March 31, 2021
Public Version Number
7
DI Record Publish Date
December 02, 2016
Package DI Number
30614559103665
Quantity per Package
100
Contains DI Package
10614559103661
Package Discontinue Date
March 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 |