Duns Number:044606982
Device Description: Endopath Electrosurgery Probe Plus II 5mm Spatula Monopolar Electrosurgery Suction and Irr Endopath Electrosurgery Probe Plus II 5mm Spatula Monopolar Electrosurgery Suction and Irrrigation Shafts with Spatula Electrode - Use only with Probe Plus II Handles
Catalog Number
EPS02
Brand Name
ENDOPATH
Version/Model Number
EPS02
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
9507f050-034d-42d9-92e5-7c404ec6cac1
Public Version Date
October 16, 2019
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
40705036012468
Quantity per Package
18
Contains DI Package
10705036012467
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 |