Duns Number:239403863
Device Description: The Secondary Trocar is used during laparoscopic procedures to create a secondary port of The Secondary Trocar is used during laparoscopic procedures to create a secondary port of entry into the abdominal cavity for use with 5mm instruments.
Catalog Number
PS3357
Brand Name
Secondary trocar with Gas Port + Additional Cannula without Gas Port
Version/Model Number
PS3357
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
6ce77865-8928-4cb5-8738-c22ddd547a8f
Public Version Date
January 09, 2020
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
35051223007457
Quantity per Package
10
Contains DI Package
05051223007456
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shelf box
| 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 |