Duns Number:239403863
Device Description: Dual spike Suction / Irrigation Set can be used during a variety of laparoscopic procedure Dual spike 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
PS3850ULT
Brand Name
Ultimate Laparoscopic Suction/Irrigation Set, Dual spike
Version/Model Number
PS3850ULT
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
35d2a3ea-e77f-49fc-980d-411272cb04bc
Public Version Date
April 23, 2019
Public Version Number
4
DI Record Publish Date
September 17, 2016
Package DI Number
35051223005750
Quantity per Package
10
Contains DI Package
05051223005759
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 |