Duns Number:044606982
Device Description: Endopath Electrosurgery Probe Plus II Pencil Hand Control Pencil Grip Handles with Suction Endopath Electrosurgery Probe Plus II Pencil Hand Control Pencil Grip Handles with Suction and Irrrigation for Hand Control Monopolar Elctrosurgery Use only with Probe Plus II Shafts
Catalog Number
EPH04
Brand Name
ENDOPATH
Version/Model Number
EPH04
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
493482d1-fb6f-45bd-b138-23e5069571b8
Public Version Date
October 16, 2019
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
30705036001878
Quantity per Package
12
Contains DI Package
10705036001874
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |