Duns Number:044606982
Device Description: Endopath XCEL Dilating Tip Trocars with Stability Sleeves
Catalog Number
D12XT
Brand Name
ENDOPATH XCEL
Version/Model Number
D12XT
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
K032676,K032676,K032676
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
bfc9cd34-dd59-4831-b398-aa7fd1796284
Public Version Date
January 09, 2020
Public Version Number
5
DI Record Publish Date
July 15, 2016
Package DI Number
30705036001588
Quantity per Package
36
Contains DI Package
10705036001584
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 |