Duns Number:239403863
Device Description: The Ultimate Dilating Tip Trocar has applications in minimally invasive surgical procedure The Ultimate Dilating Tip Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
Catalog Number
PS5461ULT
Brand Name
Dilating Tip Trocar with Threaded cannula + Additional Cannula
Version/Model Number
PS5461ULT
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
e067c04b-b7bc-4ac5-9e84-54634c6f5773
Public Version Date
January 09, 2020
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
55051223015487
Quantity per Package
20
Contains DI Package
35051223015483
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 |