Duns Number:044606982
Device Description: Endopath Dextrus Seal Cap Assembly with Accessories (Marking Pen, Ruler, and Forearm Wrap)
Catalog Number
HAP02
Brand Name
ENDOPATH DEXTRUS
Version/Model Number
HAP02
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
K070198,K070198,K070198
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
7e464917-19d7-4050-851f-965bcb5e4fcc
Public Version Date
October 16, 2019
Public Version Number
4
DI Record Publish Date
July 15, 2016
Package DI Number
30705036002059
Quantity per Package
18
Contains DI Package
10705036002055
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 |