Duns Number:527812392
Device Description: Open-surgery electrosurgical electrode, monopolar, single-use
Catalog Number
-
Brand Name
INTEGRAL PROCESS
Version/Model Number
ES871-MN271-050
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
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
7ba74300-fd62-4c0a-9c2c-c33c1fb7d8bf
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
December 12, 2017
Package DI Number
26939029815778
Quantity per Package
40
Contains DI Package
16939029815771
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 165 |