Duns Number:044606982
Device Description: Endopath Reusable Trocar Stability Sleeve for the Endopath Resposable System
Catalog Number
355RT
Brand Name
ENDOPATH
Version/Model Number
355RT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 04, 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
-
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
542942fe-222d-49bc-bca3-96123bf7110a
Public Version Date
August 05, 2021
Public Version Number
4
DI Record Publish Date
July 15, 2016
Package DI Number
40705036011973
Quantity per Package
24
Contains DI Package
20705036011979
Package Discontinue Date
August 04, 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 |