Duns Number:044606982
Device Description: Endopath Electrosurgery Probe Plus II 5mm Accessory Port Suction and Irrrigation Shafts wi Endopath Electrosurgery Probe Plus II 5mm Accessory Port Suction and Irrrigation Shafts with Accessory Port- Use only with Probe Plus II Hanldes
Catalog Number
EPS13
Brand Name
ENDOPATH
Version/Model Number
EPS13
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2016
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
0f328365-4ca1-4616-8e86-c9496124a7f9
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
July 15, 2016
Package DI Number
40705036012574
Quantity per Package
24
Contains DI Package
20705036012570
Package Discontinue Date
September 30, 2016
Package Status
Not 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 |