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.
Catalog Number
PS3835ULT
Brand Name
Ultimate Suction / Irrigation probe
Version/Model Number
PS3835ULT
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
HET
Product Code Name
Laparoscope, Gynecologic (And Accessories)
Public Device Record Key
f8d8dd5b-46b1-4baf-8107-e168ff9c88e1
Public Version Date
April 23, 2019
Public Version Number
4
DI Record Publish Date
September 17, 2016
Package DI Number
55051223007925
Quantity per Package
40
Contains DI Package
35051223007921
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping carton
| 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 |