Duns Number:044606982
Device Description: Endopath Bladeless Trocar with Stability Sleeves
Catalog Number
512NT
Brand Name
ENDOPATH
Version/Model Number
512NT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 02, 2020
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
bc6d6a1f-3053-4123-a97b-eaefdf144c86
Public Version Date
June 08, 2021
Public Version Number
4
DI Record Publish Date
July 15, 2016
Package DI Number
30705036000727
Quantity per Package
36
Contains DI Package
20705036000720
Package Discontinue Date
November 02, 2020
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |