Duns Number:239403863
Device Description: The probe attached to the Laparoscopic Suction / Irrigation Set can be used during a varie The probe attached to the Laparoscopic Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument. The 10mm diameter probe is designed for use with the PS3800 & PS3801 suction irrigation sets. It is to be used in place of the standard 5mm diameter detachable probe which is originally supplied with the suction irrigation set, in instances where a 10mm probe provides surgical advantages.
Catalog Number
PS3852
Brand Name
Laparoscopic Suction Irrigation probe, resusable
Version/Model Number
PS3852
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
-
Product Code
HET
Product Code Name
Laparoscope, Gynecologic (And Accessories)
Public Device Record Key
9e47cdcd-bb4c-43bf-b043-fcb8aa161f28
Public Version Date
April 23, 2019
Public Version Number
4
DI Record Publish Date
September 17, 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 | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |