Duns Number:044606982
Device Description: Endopath Surgical Thoracic Trocar Sleeves with Rounded Tip Obturator
Catalog Number
TT012
Brand Name
ENDOPATH
Version/Model Number
TT012
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
GEA
Product Code Name
CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
5eb993f5-dc61-483a-9ab2-40aa13cccfe8
Public Version Date
October 16, 2019
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
30705036013376
Quantity per Package
36
Contains DI Package
10705036013372
Package Discontinue Date
-
Package Status
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 |