Duns Number:185444825
Device Description: E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, 4.72 inch (12 cm), Cus E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, 4.72 inch (12 cm), Custom
Catalog Number
C117J
Brand Name
MEGADYNE
Version/Model Number
C117J
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
K081791,K081791,K081791
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
27627016-2788-404d-af8f-815d946dc5dc
Public Version Date
June 11, 2021
Public Version Number
8
DI Record Publish Date
September 05, 2018
Package DI Number
30614559105447
Quantity per Package
12
Contains DI Package
10614559105443
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |