Duns Number:044606982
Device Description: Endopath Trocar Sleeve Housings for the Endopath Resposable Trocar System
Catalog Number
355HR
Brand Name
ENDOPATH
Version/Model Number
355HR
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 19, 2021
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
67e1f28f-29c4-40f0-8223-49b7a613171c
Public Version Date
August 20, 2021
Public Version Number
5
DI Record Publish Date
July 15, 2016
Package DI Number
30705036000451
Quantity per Package
120
Contains DI Package
20705036000454
Package Discontinue Date
August 19, 2021
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 |