Duns Number:239403863
Device Description: The AutoShield Trocar is designed to provide a port of entry into the abdominal cavity dur The AutoShield Trocar is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedures.
Catalog Number
PS3516
Brand Name
Auto Shield Trocar, Ribbed, plus extra cannula
Version/Model Number
PS3516
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
d22dc167-7749-4c67-aa67-e791c47dd4db
Public Version Date
January 09, 2020
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
35051223007440
Quantity per Package
10
Contains DI Package
05051223007449
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 |