Duns Number:276593071
Device Description: Herman Bipolar Insert, Triangle Fenestrated Jaws for MCEN54P and MCEN54G
Catalog Number
MCEN54H
Brand Name
MicroFrance®
Version/Model Number
MCEN54H
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
-
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
K210942,K993655
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
5f437cb5-0d16-4703-ab25-ff0a9ca8c23d
Public Version Date
November 19, 2021
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1433 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 879 |